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AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: Gregory.Bennett@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject to certain limitations. This notice was issued in accordance with the 21st Century Cures Act (Pub. L. 114-255), which was signed into law on December 13, 2016. Section 3054 of that statute amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the 21st Century Cures Act and at least once every 5 years thereafter, FDA must publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act (generally referred to as a premarket notification or “510(k)”) to provide reasonable assurance of safety and effectiveness. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the list of devices proposed in the March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that upon the date that this final list is published in the Federal Register, a 510(k) will no longer be required for the listed devices and the applicable classification regulation for these devices shall be deemed amended to incorporate such exemption. Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. After reviewing these comments and considering whether the proposed list should be modified, FDA is now identifying its final determination as to which of those devices are now exempt from premarket notification requirements, subject to certain limitations, as indicated in tables 1 to 3 of this notice.
In a future action, FDA intends to amend the codified language for each listed device's classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw their submissions.
These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.
II. Criteria for Exemption
There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (“Class II 510(k) Exemption Guidance”) (Ref. 1).Start Printed Page 31977
III. Limitations on Exemptions
FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the exemptions found in Title 21 of the Code of Federal Regulations (CFR) sections 862.9 to 892.9 (§§ 862.9 to 892.9), when Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. Partial exemption limitations can be found in table 2 of this notice. FDA has assigned new product codes to the device types that are now exempt subject to the partial limitations in order to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code (i.e., exempt and non-exempt devices within a device type will have distinct product codes). If table 2 indicates that a partial exemption limitation does apply to a device, then affected device manufacturers should review their registration and listing information to assess if they should list their device using the original classification product code, which requires premarket notification, or the new classification product code for the subset of that device type that is now 510(k) exempt (subject to the general limitations to the exemptions found in §§ 862.9 to 892.9). In table 2, for example, FDA is listing the exemption of the tympanometer but limits the exemption to such devices that are in compliance with FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply with this partial exemption limitation and the corresponding general limitations in § 874.9 are now exempt from the 510(k) requirements and should be identified under new product code “PTP” in subsequent registration and listing submissions. However, tympanometers not in compliance with each of these exemption limitations remain subject to the 510(k) requirements and will retain product code “NAS.” We recommend that device manufacturers document in their records any changes in the product code of their device with appropriate justification.
IV. List of Class II Devices
In table 1, FDA is identifying the following list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9:
Start Printed Page 31981Table 1—Class II Devices
21 CFR section Device type Product code 862.1020 Acid Phosphatase, Nitrophenylphosphate CJN 862.1020 Acid Phosphatase, Thymol Blue Monophosphate CJR 862.1020 Acid Phosphatase, Disodium Phenylphosphate CJX 862.1020 Acid Phosphatase, Naphthyl Phosphate CKB 862.1020 Acid Phosphatase, Thymolphthale Inmonophosphate CKE 862.1020 Acid Phosphatase, Beta Glycerophosphate CKH 862.1020 Acid Phosphatase (Prostatic), Tartrate Inhibited JFH 862.1090 Radioassay, Angiotensin Converting Enzyme KQN 862.1100 Vanillin Pyruvate, AST/SGOT CIF 862.1100 Diazo, AST/SGOT CIQ 862.1100 Hydrazone Colorimetry, AST/SGOT CIS 862.1100 NADH Oxidation/NAD Reduction, AST/SGOT CIT 862.1150 Calibrator, Primary JIS 862.1150 Calibrator, Secondary JIT 862.1150 Calibrator, Surrogate JIW 862.1150 Calibrator, Multi-Analyte Mixture JIX 862.1345 Drink, Glucose Tolerance MRV 862.1350 Continuous Glucose Monitor Secondary Display PJT 862.1445 Chromatographic Separation, Lactate Dehydrogenase Isoenzymes CEX 862.1445 Electrophoretic, Lactate Dehydrogenase Isoenzymes CFE 862.1445 Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes JGF 862.1509 System, Test, Urinary Methylmalonic Acid LPT 862.1685 Radioimmunoassay, Thyroxine-Binding Globulin CEE 862.1700 Radioimmunoassay, Total Thyroxine CDX 862.1700 Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI 862.2265 High Throughput DNA Sequence Analyzer PFF 862.2570 Instrumentation For Clinical Multiplex Test Systems NSU 862.2570 Real Time Nucleic Acid Amplification System OOI 862.2570 Mass Spectrometer For Clinical Multiplex Test Systems OTA 862.2570 Micro Total Analysis Instrument System OUE 862.2570 Complete Gene Expression Profiling Accessory Reagents OVA 862.2570 DNA Genetic Analyzer PCA 862.2570 Data Acquisition Software PQQ 862.3200 Calibrators, Drug Mixture DKB 862.3200 Calibrators, Drug Specific DLJ Start Printed Page 31978 862.3200 Calibrators, Ethyl Alcohol DNN 864.5400 Fibrometer GIE 864.5400 Timer, Coagulation JBT 864.5425 Control, Plasma, Abnormal GGC 864.5425 Plasma, Coagulation Control GGN 864.5425 Plasma, Control, Normal GIZ 864.6550 Control, Fecal Occult Blood OSL 864.6650 Study, Platelet Adhesive JBZ 864.7275 Test, Euglobulin Lysis JBO 864.7300 Fibrin Monomer Paracoagulation JBN 864.7340 Fibrinogen Standard GFX 864.7340 Plasma, Fibrinogen Control GIL 864.7375 Glutathione, Red-Cell GII 864.7375 Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase JMH 864.7375 Assay, Glutathione Reductase KQF 864.7415 Control, Hemoglobin, Abnormal JCM 864.7455 Stain, Fetal Hemoglobin GHQ 864.7500 Acid Hematin GGF 864.7720 Test, Prothrombin Consumption GGQ 864.7735 Prothrombin-Proconvertin and Thrombotest JPF 864.8150 Calibrator for Cell Indices KRX 864.8165 Calibrator for Hemoglobin and Hematocrit Measurement KRZ 864.8175 Calibrator for Platelet Counting KRY 864.8185 Calibrator for Red-Cell and White-Cell Counting KSA 864.8625 Standards and Controls, Hemoglobin, Normal and Abnormal GFS 864.8625 Control, White-Cell GGL 864.8625 Control, Hemoglobin GGM 864.8625 Control, Platelet GJP 864.8625 Control, Red-Cell GJR 864.8625 Control, Hematocrit GLK 864.8625 Mixture, Control, White-Cell and Red-Cell Indices GLQ 864.8625 Control, Cell Counter, Normal and Abnormal JCN 864.8625 Mixture, Hematology Quality Control JPK 864.8625 Material, Quality Control, Semen Analysis NRF 864.8625 Control Material, Blood Circulating Epithelial Cancer Cell NRS 864.9400 Solution, Stabilized Enzyme KSK 866.3395 Norovirus Serological Reagents OUC 866.5210 Immunochemical, Ceruloplasmin CHN 866.5210 Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control DCT 866.5210 Ceruloplasmin, FITC, Antigen, Antiserum, Control DCY 866.5210 Ceruloplasmin, Antigen, Antiserum, Control DDB 866.5210 P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin JFQ 866.5210 Indirect Copper Assay, Ceruloplasmin JFR 866.5470 Hemoglobin, Chain Specific, Antigen, Antiserum, Control DAM 866.5620 Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control DDT 866.5620 Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control DDY 866.5620 Alpha-2-Macroglobulin, Antigen, Antiserum, Control DEB 866.5630 System, Test, Beta-2-Microglobulin Immunological JZG 866.5910 Quality Control Material, Genetics, DNA NZB 868.1040 Algesimeter, Powered BSI 868.1400 Legging, Compression, Non-Inflatable LLK 868.2500 Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK 868.2500 Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP 868.2550 Pneumotachometer JAX 868.5180 Bed, Rocking, Breathing Assist CCO 868.6250 Compressor, Air, Portable BTI 870.1390 Trocar DRC 870.1875 Lung Sound Monitor OCR 870.2675 Oscillometer DRZ 870.4280 Filter, Prebypass, Cardiopulmonary Bypass KRJ 870.4290 Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL 870.4340 Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass DTW 870.4420 Sucker, Cardiotomy Return, Cardiopulmonary Bypass DTS 870.4430 Suction Control, Intracardiac, Cardiopulmonary Bypass DWD 872.1720 Tester, Pulp EAT 872.3260 External Cleaning Solution PME 872.3300 Coating, Denture Hydrophilic, Resin EBE 872.3540 Pad, Denture, Over The Counter EHR 872.3540 Cushion, Denture, Over The Counter EHS 872.3560 Reliner, Denture, Over The Counter EBP 872.3590 Denture, Plastic, Tooth ELM Start Printed Page 31979 872.3600 Denture Preformed (Partially Prefabricated Denture) EKO 872.3890 Splint, Endodontic Stabilizing ELS 872.5550 Ring, Teething, Fluid-Filled KKO 872.6770 Syringe, Cartridge EJI 874.1120 Generator, Electronic Noise (for Audiometric Testing) ETS 874.1325 Electroglottograph KLX 874.3310 Calibrator, Hearing Aid/Earphone and Analysis Systems ETW 874.3320 Hearing Aid, Group and Auditory Trainer EPF 874.3320 Device, Assistive Listening LZI 874.3330 Hearing Aid, Master KHL 874.3430 Mold, Middle-Ear ETC 874.3730 Device, Voice Amplification MCK 876.1500 Light Source, Incandescent, Diagnostic FCQ 876.1500 Light Source, Photographic, Fiberoptic FCR 876.1500 Light Source, Fiberoptic, Routine FCW 876.1500 Carrier, Sponge, Endoscopic FGS 876.1500 Light Source, Endoscope, Xenon Arc GCT 876.1500 Transformer, Endoscope GCW 876.1500 LED Light Source NTN 876.1500 Endoscopic Guide Wire, Gastroenterology-Urology OCY 876.4020 Light, Catheter, Fiberoptic, Glass, Ureteral FCS 876.4270 Rod, Colostomy EZP 876.4400 Ligator, Hemorrhoidal FHN 876.4400 Ligator, Esophageal MND 876.4500 Lithotriptor, Biliary Mechanical LQC 876.4770 Urethrotome EZO 876.5010 Bag, Bile Collecting EXF 876.5025 Vibrator for Climax Control of Premature Ejaculation PIA 876.5365 Dilator, Esophageal (Metal Olive) Gastro-Urology EZM 876.5365 Bougie, Esophageal, and Gastrointestinal, Gastro-Urology FAT 876.5365 Dilator, Esophageal KNQ 876.5520 Dilator, Urethral KOE 876.5665 Disinfectant, Subsystem, Water Purification NIH 876.5820 Set, Dialyzer Holder FKI 876.5895 Irrigator, Ostomy EXD 876.5980 Catheter, Retention, Barium Enema With Bag FGD 876.5980 Gastrostomy Tube Holder PLI 878.4370 Drape, Surgical, ENT ERY 878.4370 Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX 878.4370 Drape, Urological, Disposable EYY 878.4370 Pad, Kelly FNW 878.4370 Drape, Patient, Ophthalmic HMT 878.4370 Drape, Microscope, Ophthalmic HMW 878.4370 Ring (Wound Protector), Drape Retention, Internal KGW 878.4580 Lamp, Operating-Room FQP 878.4580 Light, Surgical, Instrument FSQ 878.4580 Light, Surgical, Floor Standing FSS 878.4580 Light, Surgical, Endoscopic FSW 878.4580 Light, Surgical, Connector FSX 878.4580 Light, Surgical, Ceiling Mounted FSY 878.4580 Light, Surgical, Carrier FSZ 878.4580 Light, Surgical, Accessories FTA 878.4580 Lamp, Surgical FTD 878.4580 Illuminator, Remote FTG 878.4580 Lamp, Surgical, Incandescent GBC 878.5070 Apparatus, Air Handling, Bench FZG 878.5070 Apparatus, Air Handling, Room FZH 878.5070 Apparatus, Air Handling, Enclosure FZI 880.5580 Locator, Acupuncture Point BWJ 880.5580 Needle, Acupuncture, Single Use MQX 880.5780 Stocking, Medical Support (to Prevent Pooling of Blood in Legs) DWL 882.1020 Analyzer, Rigidity GZM 882.1540 Device, Galvanic Skin Response Measurement GZO 882.1560 Device, Skin Potential Measurement HCJ 882.1855 Encephalogram Telemetry System GYE 882.5895 Vibratory Counter-Stimulation OVP 884.2990 Sheet, Recording, Breast Examination NHM 884.3200 Drain, Cervical HFL 884.4400 Forceps, Obstetrical HDA 884.4530 Clamp, Umbilical HFW 884.4530 Speculum, Vaginal, Nonmetal HIB Start Printed Page 31980 884.4530 Speculum, Vaginal, Nonmetal, Fiberoptic HIC 884.4530 Clamp and Cutter, Umbilical NBZ 884.4900 Table, Obstetrical, AC-Powered (and Accessories) HDD 884.4900 Table, Obstetrical, Manual (and Accessories) HHP 884.4900 Table, Obstetric (and Accessories) KNC 884.5200 Hemorrhoid Prevention Pressure Wedge OOA 884.5390 Heater, Perineal, Direct Contact HGZ 884.5390 Heater, Perineal, Radiant, Non-Contact HHA 884.5390 Heater, Perineal KND 884.5400 Cup, Menstrual HHE 884.5425 Pad, Menstrual, Scented HHL 884.6150 Micromanipulators and Microinjectors, Assisted Reproduction MQJ 886.1120 Photorefractor MMF 886.1120 Camera, Ophthalmic, General-Use PJZ 886.1250 Euthyscope, AC-Powered HMK 886.1570 Ophthalmoscope, AC-Powered HLI 886.1570 Ophthalmoscope, Battery-Powered HLJ 886.1570 Ophthalmoscopes, Replacement Batteries, Hand-Held MSG 886.1780 Retinoscope, AC-Powered HKL 886.1945 Transilluminator, AC-Powered HJM 886.4150 Tubing, Replacement, Phacofragmentation Unit MSR 886.4250 Unit, Electrolysis, AC-Powered, Ophthalmic HRO 886.4335 Headlight, Fiberoptic Focusing FCT 886.4335 Light, Headband, Surgical FSR 886.4335 Headlamp, Operating, AC-Powered HPQ 886.4400 Locator, Metal, Electronic HPM 886.4440 Magnet, AC-Powered HPO 886.4790 Sponge, Ophthalmic HOZ 886.4790 Eye Tray OJK 888.1240 Dynamometer, AC-Powered LBB 888.4580 Instrument, Surgical, Sonic and Accessory/Attachment JDX 888.4580 System, Cement Removal Extraction LZV 890.1450 Hammer, Reflex, Powered IKO 890.5100 Bath, Hydro-Massage ILJ 890.5100 Bath, Sitz, Powered ILM 890.5110 Bath, Paraffin IMC 890.5250 Cabinet, Moist Steam IMB 890.5360 Exerciser, Measuring ISD 890.5500 Lamp, Infrared, Therapeutic Heating ILY 890.5575 Device, Warning, Overload, External Limb, Powered IRN 892.1000 MRI Disposable Kit OIM 892.1560 Biopsy Needle Guide Kit OIJ 892.1610 Aperature, Radiographic IZS 892.1610 Cone, Radiographic IZT 892.1610 Collimator, Automatic, Radiographic IZW 892.1610 Collimator, Manual, Radiographic IZX 892.1610 Device, Beam Limiting, X-Ray, Diagnostic KPW 892.1650 Arthrogram Tray OII 892.1650 Radiology Dental Tray OIK 892.1670 Device, Spot-Film IXL 892.1680 Radiographic Contrast Tray OIO 892.1680 Radiology Diagnostic Kit OIP 892.1730 Discography Kit OIL 892.1820 Chair, Pneumocephalographic HBK 892.1850 Cassette, Radiographic Film IXA 892.1860 Changer, Radiographic Film/Cassette KPX 892.1870 Programmer, Changer, Film/Cassette, Radiographic IZP 892.1900 Controller, Temperature, Radiographic EGT 892.1900 Dryer, Film, Radiographic EGW 892.1900 Processor, Radiographic-Film, Automatic, Dental EGY 892.1900 Processor, Radiographic-Film, Automatic IXW 892.1900 Processor, Cine Film IXX 892.2030 Digitizer, Image, Radiological LMA 892.2030 Digitizer, Images, Ophthalmic NFH 892.2040 Camera, Multi Format, Radiological LMC 892.2040 Device, Hardcopy, Images, Ophthalmic NFI 892.5730 Prostate Seeding Kit OIN In table 2, FDA is identifying a list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9, as well as the indicated partial exemption limitations. Devices listed in table 2 are now exempt, but only if they are in concurrent compliance with both the partial exemption limitation specified in table 2 and its corresponding general limitation found in the .9 section of Parts 862 to 892 of Title 21 of the CFR.
Table 2—Class II Devices
21 CFR Section Device type Exempt product code Former product code (non-exempt) Partial exemption limitation 862.3100 Enzyme Immunoassay, Amphetamine PUX DKZ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100 Radioimmunoassay, Amphetamine PUX DJP Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100 Thin Layer Chromatography, Amphetamine PUX DIT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100 Gas Chromatography, Amphetamine PUX DOD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100 Liquid Chromatography, Amphetamine PUX DNI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3100 Free Radical Assay, Amphetamine PUX DJL Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150 Enzyme Immunoassay, Barbiturate PUY DIS Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31982 862.3150 Radioimmunoassay, Barbiturate PUY DKN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150 Thin Layer Chromatography, Barbiturate PUY DKX Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150 Mercury Dithiazone, Colorimetry, Barbiturate PUY DJN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150 Hemagglutination Inhibition, Barbiturate PUY DLX Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150 Gas Liquid Chromatography, Barbiturate PUY DMF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3150 High Pressure Liquid Chromatography, Barbiturate PUY KZY Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170 Enzyme Immunoassay, Benzodiazepine PUZ JXM Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170 High Pressure Liquid Chromatography, Benzodiazepine PUZ LAA Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31983 862.3170 Test, Benzodiazepine, Over The Counter PUZ NFV Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170 Gas Chromatography, Benzodiazepine PUZ KZZ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3170 Thin Layer Chromatography, Benzodiazepine PUZ LAB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Enzyme Immunoassay, Cocaine and Cocaine Metabolites PVA DIO Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Radioimmunoassay, Cocaine Metabolite PVA KLN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Enzyme Immunoassay, Cocaine PVA JXO Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Hemagglutination, Cocaine Metabolites (Benzoylecgonine) PVA DLN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Thin Layer Chromatography, Cocaine PVA DMN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31984 862.3250 Free Radical Assay, Cocaine PVA DIR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Gas Chromatography, Cocaine PVA DIN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 Thin Layer Chromatography, Benzoylecgonine PVA DOM Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3250 High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites PVA LAC Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3270 High Pressure Liquid Chromatography, Codeine PVB LAE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3270 Thin Layer Chromatography, Codeine PVB DLD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3270 Gas Chromatography, Codeine PVB LAD Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3580 Radioimmunoassay, LSD (125-I) PVC DLB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31985 862.3580 Free Radical Assay, LSD PVC DOL Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610 Gas Chromatography, Methamphetamine PVD LAF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610 Thin Layer Chromatography, Methamphetamine PVD DJC Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610 High Pressure Liquid Chromatography, Methamphetamine PVD LAG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3610 Test, Methamphetamine, Over The Counter PVD NGG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620 Enzyme Immunoassay, Methadone PVE DJR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620 Hemagglutination Inhibition, Methadone PVE DIW Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620 Gas Chromatography, Methadone PVE DMB Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31986 862.3620 Thin Layer Chromatography, Methadone PVE DKR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620 Liquid Chromatography, Methadone PVE DNT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3620 Free Radical Assay, Methadone PVE DPP Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3630 Radioimmunoassay, Methaqualone PVF KXS Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Thin Layer Chromatography, Morphine PVG DNK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. PVG DOE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Fluorometry, Morphine PVG DJJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Liquid Chromatography, Morphine PVG DPK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31987 862.3640 Gas Chromatography, Morphine PVG DMY Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Hemagglutination Inhibition, Morphine PVG DLR Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Free Radical Assay, Morphine PVG DOK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. PVG DIQ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3640 Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody PVG DNA Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650 Enzyme Immunoassay, Opiates PVH DJG Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650 Gas Chromatography, Opiates PVH DJF Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650 Hemagglutination, Opiates PVH DLT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31988 862.3650 Thin Layer Chromatography, Opiates PVH LAI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650 Free Radical Assay, Opiates PVH DKT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3650 High Pressure Liquid Chromatography, Opiates PVH LAH Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700 Enzyme Immunoassay, Propoxyphene PVI JXN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700 Thin Layer Chromatography, Propoxyphene PVI DPN Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700 Gas Chromatography, Propoxyphene PVI LAJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3700 High Pressure Liquid Chromatography, Propoxyphene PVI LAK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3870 Enzyme Immunoassay, Cannabinoids PVJ LDJ Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Start Printed Page 31989 862.3870 Reagents, Test, Tetrahydrocannabinol PVJ DKE Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3870 Radioimmunoassay, Cannabinoid(S) PVJ LAT Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3910 High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs PVK LFI Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3910 U.V. Spectrometry, Tricyclic Antidepressant Drugs PVK LFH Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 862.3910 Thin Layer Chromatography, Tricyclic Antidepressant Drugs PVK MLK Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) 866.5750 System, Test, Radioallergosorbent (RAST) Immunological PUW DHB Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document. 868.2385 Analyzer, Nitrogen Dioxide PUG MRQ Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. 870.1330 Wire, Guide, Catheter PTL DQX Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires. 870.1650 Syringe, Balloon Inflation PTM MAV Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. 870.2770 Analyzer, Body Composition PUH MNW Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition. 870.4400 Reservoir, Blood, Cardiopulmonary Bypass PTN DTN Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters. 874.1090 Tester, Auditory Impedance PTO ETY Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39. 874.1090 Tympanometer PTP NAS Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39. 876.1500 Endoscopic Magnetic Retriever PTQ FCC Exemption is limited to endoscopic magnetic retrievers intended for single use. 876.1500 Scissors For Cystoscope PTR KGD Exemption is limited to sterile scissors for cystoscope intended for single use. Start Printed Page 31990 876.1500 Endoscopic Grasping/Cutting Instrument, Non-Powered PTS OCZ Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use. 876.5010 Catheter, Biliary, Surgical PTT GCA Exemption is limited to surgical biliary catheters that do not include a balloon component. 876.5630 Catheter, Peritoneal, Long-Term Indwelling PTU FJS Exemption is limited to non-patient contacting catheter finger grips intended for single use. 876.5630 Catheter, Peritoneal Dialysis, Single Use PTV FKO Exemption is limited to non-patient contacting catheter finger grips intended for single use. 876.5630 System, Peritoneal, Automatic Delivery PTW FKX Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales. 878.4370 Drape, Surgical PUI KKX Exemption is limited to surgical drapes that do not include an antimicrobial agent. 878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile PTX GAQ Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs. 882.1470 Computerized Cognitive Assessment Aid PTY PKQ Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand. 884.1630 Colposcope (and Colpomicroscope) PTZ HEX Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. 884.4530 Tenaculum, Uterine PUA HDC Exemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use. 884.6120 Accessory, Assisted Reproduction PUB MQG Exemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers. 884.6130 Microtools, Assisted Reproduction (Pipettes) PUC MQH Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass. 884.6160 Labware, Assisted Reproduction PUD MQK Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures. 886.1850 Biomicroscope, Slit-Lamp, AC-Powered PUE HJO Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. 886.3320 Ocular Peg PUF MQU Exemption is limited to ocular pegs supplied sterile. In table 2, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system). FDA does not believe that all devices classified under this regulation meet the exemption criteria from premarket notification requirements. The devices listed in table 3 are also classified under § 866.5750, but this subset no longer requires premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in § 866.9. While the non-exempt devices classified under § 866.5750 will retain product code “DHB”, these devices listed in table 3 are reassigned product code “PUW.”
Start Printed Page 32002Table 3—Class II Devices
[§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]
Allergen code Allergen product Source (taxonomical name) Grass Pollens g1 Sweet vernal grass Anthoxanthum odoratum. g3 Cocksfoot grass, Orchard grass Dactylis glomerata. g4 Meadow fescue Festuca elatior. g5 Rye-grass (perennial rye grass) Lolium perenne. g7 Common reed (common reed grass) Phragmites communis. g8 Meadow grass, Kentucky blue (June grass) Poa pratensis. Start Printed Page 31991 g9 Redtop, Bentgrass Agrostis stolonifera Agrostis gigantea (Agrostis alba). g11 Brome grass Bromus inermis. g12 Cultivated rye (cultivated rye grass) Secale cereale. g13 Velvet grass Holcus lanatus. g14 Cultivated oat (cultivated oat grass) Avena sativa. g15 Cultivated wheat (cultivated wheat grass) Triticum aestivum (Triticum spp.). g16 Meadow foxtail (meadow foxtail grass) Alopecurus pratensis. g17 Bahia grass Paspalum notatum. g24 Wheat grass, Western Agropyron smithii (Elymus smithii). g30 Bluegrass, annual Poa annua. g70 Wild rye grass Elymus triticoides Elymus condensatus. g71 Canary grass Phalaris arundinacea. g201 Barley, cultivated Hordeum vulgare. g202 Maize, corn (cultivated corn) Zea mays. g203 Salt grass Distichlis spicata. g204 False oat-grass Arrhenatherum elatius. g216 Cyn d 1 Cynodon dactylon. g701 Phl p 1.0102, Phl p 5.0101 Phleum pratense. g702 Phl p 7.0101 Phleum pratense. g703 Phl p 12.0101 Phleum pratense. Weed Pollens w2 Western ragweed Ambrosia psilostachya. w4 False ragweed Ambrosia acanthicarpa (Franseria acanthicarpa). w5 Wormwood Artemisia absinthium Artemisia annua. w6 Mugwort Artemisia vulgaris. w7 Marguerite, ox-eye daisy Chrysanthemum leucanthemum. w8 Dandelion Taraxacum vulgare Taraxacum officinale. w9 Plantain (English), Ribwort Plantago lanceolata. w10 Goosefoot, lamb's quarters Chenopodium album. w11 Saltwort (prickly), Russian thistle Salsola kali (Salsola pestifer). w12 Goldenrod Solidago virgaurea (Solidago spp.) w13 Cocklebur, common Xanthium commune. w14 Common pigweed (rough pigweed) Amaranthus retroflexus. w15 Scale, Lenscale Atriplex lentiformis. w16 Rough marsh elder Iva ciliate Iva annua. w17 Firebush (Kochia) Kochia scoparia. w18 Sheep sorrel Rumex acetosella. w19 Wall pellitory Parietaria officinalis. w20 Nettle (Common stinging nettle) Urtica dioica. w21 Wall pellitory Parietaria judaica. w22 Japanese hop (careless weed) Humulus japonicas (Humulus scandens). w23 Yellow dock, Yellow dockweed Rumex crispus. w24 Spiny pigweed Amaranthus spinosus. w27 Carnation Dianthus spp. w28 Rose Rosa rugosa. w33 Clover Trifolium pratense. w35 Mexican tea Chenopodium ambrosioides. w36 Rabbit bush Ambrosia deltoidea (Franseria deltoides). w37 Salt bush, annual Atriplex wrightii. w39 Water hemp, Western Amaranthus rudis (Acnida tamariscina). w41 Burrobrush Hymenoclea salsola. w42 Poverty weed w43 Common sagebrush Artemisia tridentata. w45 Alfalfa Medicago sativa. w46 Dog fennel Eupatorium capillifolium. Start Printed Page 31992 w53 Geranium Geranium spp. w67 Groundsel bush Baccharis halimifolia. w69 Iodine bush Allenrolfea occidentalis. w70 Ragweed, slender Ambrosia confertiflora. w75 Wing scale (wingscale) Atriplex canescens. w82 Careless weed Amaranthus palmeri Amaranthus hybridus. w90 Japanese hop Humulus japonicas (Humulus scandens). w203 Rape (rape pollen) Brassica napus. w204 Sunflower Helianthus annuus. w206 Camomile Matricaria chamomilla. w207 Lupin Lupinus spp. w210 Sugar-beet Beta vulgaris. w211 Par j 2.0101 Parietaria judaica. w231 Art v 1 Artemisia vulgaris (Mugwort). w232 Sal k 1 Salsola kali. w233 Art v 3 Artemisa vulgaris (LTP, Mugwort). w234 Pla l 1 Plantago lanceolata. w235 Che a 1.0101 Chenopodium album. w236 Mer a 1.0101 Mercurialis annua. a753 Art v 1 Artemisia vulgaris (Mugwort weed). Tree Pollens t1 Box-elder (Maple) Acer negundo. Acer saccharum. t2 Gray alder, speckled alder (alder) Alnus incana. t4 Hazel, hazelnut Corylus avellana. Corylus americana. t5 American beech (beech) Fagus grandifolia. (Fagus americana). t6 Mountain juniper, Mountain cedar Juniperus ashei (Juniperus sabinoides). t8 Elm Ulmus americana. t9 Olive Olea europaea. t10 Walnut Juglans californica Juglans nigra. t11 Maple leaf sycamore, London plane, Plane tree Platanus acerifolia. t61 Sycamore Platanus occidentalis. t12 Willow Salix caprea Salix nigra. t14 Cottonwood (Eastern Cottonwood/Black Cottonwood) Populus deltoides. t15 White ash Fraxinus americana. t16 White pine Pinus strobus. t18 Eucalyptus, gum-tree Eucalyptus globulus. (Eucalyptus spp.). t19/t26 Acacia Acacia longifolia (Acacia spp.). t20 Mesquite Prosopis glandulosa/ Prosopis juliflora. t21 Melaleuca, cajeput tree Melaleuca quinquenervia (Melaleuca leucadendron). t22 Pecan, hickory Carya illinoinensis (Carya pecan). t23 Italian/Mediterranean/funeral cypress Cupressus sempervirens. t24 Japanese cypress Chamaecyparis obtusa (Chamaecyparis spp.). t25 Ash Fraxinus excelsior. t27 Maple, red Acer rubrum. t29 Acacia Acacia spp. t30 Birch, white Betula populifolia. t32 Willow, black Salix nigra. t33 Ash, Arizona Fraxinus velutina. t35 Cedar, salt Tamarix gallica. t37 Bald cypress (white bald cypress) Taxodium distichum. t38 Elm, Chinese/Siberian Ulmus pumila. t40 Hazelnut tree Corylus americana. t41 White hickory Carya alba (Carya tomentosa). t42 Oak, red Quercus rubra. t43 Loblolly pine Pinus taeda. t44 Hackberry Celtis occidentalis. Start Printed Page 31993 t45 Cedar elm Ulmus crassifolia. t47 Juniper, one seed Juniperus monosperma. t48 Pine, lodgepole Pinus contorta. t49 Pine, ponderosa Pinus ponderosa. t50 Beech, European Fagus sylvatica. t51 Tree of Heaven Ailanthus altissima. t52 Western white pine Pinus monticola. t54 Russian olive Elaeagnus angustifolia. t55 Scotch broom Cytisus scoparius. t56 Bayberry Myrica cerifera. t57 Red cedar Juniperus virginiana. t60 Western juniper Juniperus occidentalis. t61 Sycamore Platanus occidentalis. t70 Mulberry (white mulberry) Morus alba. t71 Red mulberry Morus rubra. t72 Queen palm Arecastrum romanzoffiamon. t73 Australian pine Casuarina equisetifolia. t77 Oak mix (red, white, black) Quercus spp. t80 Japanese cypress Chamaecyparis obtusa. t81 Japanese alder Alnus japonica. t83 Mango tree Mangifera indica. t90 Walnut, black Juglans nigra. t96 Poplar, white (poplar) Populus alba. t103/ t218 Virginia live oak (live oak) Quercus virginiana. t105 Pepper tree Schinus molle. t110 Orange tree Citrus sinensis. t201 Spruce, Norway spruce Picea abies (Picea excelsa). t202 Alder, smooth Alnus incana spp. Rugosa (Alnus rugosa). t203 Horse chestnut Aesculus hippocastanum. t205 Elder Sambucus nigra. t206 Chestnut Castanea sativa. t207 Douglas fir Pseudotsuga menziesii (Pseudotsuga taxifolia). t208 Linden Tilia cordata. t209 Horn beam Carpinus betulus. t210 Privet Ligustrum vulgare. t211 Sweet gum Liquidambar styraciflua. t212 Cedar Libocedrus decurrens. t213 Pine Pinus radiata. t214 Date palm Phoenix canariensis. t215 Lilac Syringa vulgaris. t217 Pepper tree Schinus molle. t217 Red alder Alnus rubra. t218 Virginia live oak Quercus virginiana. t218 Bayberry (bayberry/sweet gale) Myrica gale. t219 Palo verde Cercidium floridum. t219 Red cedar Juniperus virginiana. t220 Bet v 4 Betula verrucosa (Birch). t221 Bet v 2.0101, Bet v 4 Betula verrucosa (Birch). t222 Cypress (Arizona cypress) Cupressus arizonica. t223 Oil palm Elaeis guineensis. t224 Ole e 1 Olea europaea. t225 Bet v 6 Betula verrucosa (Birch). t226 Cup a 1 Cupressus arizonica. t227 Ole e 7 Olea Europaea. t228 Aspen, quaking Populus tremuloides. t229 Eastern hemlock Tsuga canadensis. t230 Redwood (sequoia) Sequoia sempervirens. t232 Pussy willow Salix discolor. t240 Ole e 9.0101 Olea Europaea. t241 Pla a 1.0101 Platanus acerifolia. t242 Pla a 2 Platanus acerifolia. t243 Pla a 3.0101 Platanus acerifolia. t244 Cor a 1.0103 Corylus avellana. t245 Aln g 1.0101 Alnus glutinosa. t246 Cry j 1 Cryptomeria japonica. t280 Locust tree Robinia pseudoacacia. t401 Brazilian peppertree Schinus terebinthifolius. t402 Mastic tree Pistacia lentiscus. Start Printed Page 31994 t404 Tree of heaven Ailanthus altissima. t406 Date palm Phoenix dactylifera. a482 Ole e 1 Olea europaea (Olive Oil). Mites d207 Blo t 5.0101 Blomia tropicalis. d208 Lep d 2.0101 Lepidoglyphus destructor. Microorganisms, Molds, Yeast m1 Penicillium chrysogenum (Penicillium notatum) Penicillium chrysogenum (Penicillium notatum). m2 Cladosporium herbarum (Hormodendrum) Cladosporium herbarum (Hormodendrum). m3 Aspergillus fumigatus Aspergillus fumigatus. m4 Mucor racemosus Mucor racemosus. m5 Candida albicans Candida albicans. m7 Botrytis cinerea Botrytis cinerea. m8 Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum) Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes). m9 Fusarium moniliforme (Fusarium proliferatum) Fusarium moniliforme (Fusarium proliferatum). m10 Stemphylium botryosum Stemphylium herbarum (Stemphylium botryosum). m11 Rhizopus nigricans Rhizopus nigricans. m12 Aureobasidium pullulans Aureobasidium pullulans. m13 Phoma betae Phoma betae. m14 Epicoccum purpurascens Epicoccum purpurascens (Epicoccum nigrum). m15 Trichoderma viride Trichoderma viride. m16 Curvularia lunata Curvularia lunata Curvularia specifera (K923044). m17 Cladosporium fulvum Cladosporium fulvum. m18 Fusarium culmorum Fusarium culmorum. m19 Aspergillus versicolor Aspergillus versicolor. m20 Mucor mucedo Mucor mucedo. m21 Aspergillus clavatus Aspergillus clavatus. m22 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni). m23 Thermoactinomyces vulgaris Thermoactinomyces vulgaris. m24 Stachybotrys atra Stachybotrys chartarum (Stachybotrys atra). m24 Paecilomyces spp. Paecilomyces spp. m25 Aspergillus versicolor Aspergillus versicolor. m25 Penicillium brevicompactum Penicillium brevicompactum. m26 Cladosporium cladosporioides Cladosporium cladosporioides. m26 Penicillium citrinum Penicillium citrinum. m27 Penicillium spp. Penicillium spp. m29 Aspergillus repens Aspergillus repens. m30 Penicillium roqueforti Penicillium roqueforti. m32 Cladosporium cladosporioides Cladosporium cladosporioides. m34 Serpula lacrymans Serpula lacrymans. m36 Aspergillus terreus Aspergillus terreus. m37 Trichophyton mentagrophytes Trichophyton mentagrophytes. m40 Aspergillus amstelodami Aspergillus amstelodami. m43 Saccharomyces carlsberg Saccharomyces carlsbergensis. m44 Saccharomyces cerevisiae Saccharomyces cerevisiae. m45 Hormodendrum hordei Hormodendrum hordei. m46 Bipolaris spicifera Bipolaris spicifera. m47 Aspergillus nidulans Aspergillus nidulans. m48 Aspergillus oryzae Aspergillus oryzae. m49 Fusarium oxysporum Fusarium oxysporum. m50 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni). m51 Thermoactinomyces vulgaris Thermoactinomyces vulgaris. m53 Microspora canis Microsporum canis (Microspora canis). m54 Aspergillus flavus Aspergillus flavus. m63 Helminthosporium intersemin Helminthosporium intersemin. m66 Mucor plumbeus Mucor plumbeus. m67 Mycogone Mycogone perniciosa. m68 Nigrospora oryzae Nigrospora oryzae. Start Printed Page 31995 m69 Rhodotorula Rhodotorula rubra (Rhodotorula mucilaginosa). m70 Malassezia furfur (Pityrosporum orbiculare) Malassezia furfur (Pityrosporum orbiculare). m71 Spondylocladium Spondylocladium spp. m72 Epidermophyton Epidermophyton floccosum. m73 Epicoccum nigrum Epicoccum purpurascens (Epicoccum nigrum). m80 Staphylococcal enterotoxin A (Sta a SEA) Staphylococcus aureus. m80 Helminthosporium spp. Helminthosporium spp. m81 Staphylococcal enterotoxin B (Sta a SEB) Staphylococcus aureus. m88 Stemphylium solani Stemphylium solani. m93 Gliocladium fimbriatum Gliocladium fimbriatum. m94 Phycomyces blakesleeanus Phycomyces blakesleeanus. m201 Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut) Tilletia tritici (Ustilago nuda, Ustilago tritici). m202 Acremonium kiliense (Cephalosporium acremonium) Acremonium kiliense (Cephalosporium acremonium). m203 Trichosporon pullulans Trichosporon pullulans. m204 Ulocladium chartarum Ulocladium chartarum. m205 Trichophyton rubrum Trichophyton rubrum. m207 Aspergillus niger Aspergillus niger. m208 Chaetomium globosum Chaetomium globosum. m209 Penicillium frequentans Penicillium glabrum (Penicillium frequentans). m209 Stachybotrys chartarum Stachybotrys chartarum (Stachybotrys atra). m210 Trichophyton mentagrophytes var. goetzii Trichophyton mentagrophytes var. goetzii. m211 Trichophyton mentagrophytes var. interdigitale Trichophyton mentagrophytes var. interdigitale. m211 Oat smut Ustilago avenae. m212 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni). m212 Geotrichum candidum Geotrichum candidum. m213 Bermuda grass smut Ustilago cynodontis. m214 Johnson grass smut Sphacelotheca cruenta. m215 Corn smut Ustilago maydis. m218 Asp f 1.0101 Aspergillus fumigatus. a3050 Asp r 1 Aspergillus restrictus. m219 Asp f 2 Aspergillus fumigatus. m220 Asp f 3.0101 Aspergillus fumigatus. m221 Asp f 4 Aspergillus fumigatus. m222 Asp f 6.0101 Aspergillus fumigatus. m223 Staphylococal enterotoxin C (Sta a SEC) Staphylococus aureus. m224 Staphylococcal enterotoxin D (Sta a SED) Staphylococcus aureus. m226 Staphylococcal enterotoxin TSST (Sta a TSST) Staphylococcus aureus. m227 Malassezia spp. (Pityrosporum spp.) Malassezia spp. (Pityrosporum spp.). m228 Aspergillus flavus. m229 Alt a 1.0101 Alternaria alternata (Alternaria tenuis). m230 Alt a 6.0101 Alternaria alternata (Alternaria tenuis). m231 Cla h 8.0101 Cladosporium herbarum (Hormodendrum). m300 Eurotium spp. Eurotium spp. m304 Aspergillus oryzae Aspergillus oryzae. m305 Penicillium brevicompactum Penicillium brevicompactum. m309 Aspergillus terreus Aspergillus terreus. m310 Aspergillus nidulans Aspergillus nidulans. m311 Aspergillus flavus Aspergillus flavus. m312 Aspergillus clavatus Aspergillus clavatus. Epidermal & Animal e6 Guinea pig epithelium Cavia porcellus. e7 Pigeon droppings Columba palumbus Columba livia. e25 Chicken serum Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26 Parrot serum Psittacoidea spp. e62 Camel Camelus dromedaries. e70 Goose feathers Anser anser. e71 Mouse epithelium Mus musculus (Mus spp.). e73 Rat epithelium Rattus norvegicus. e74 Rat urine proteins Rattus norvegicus Rattus rattus. Start Printed Page 31996 e75 Rat serum proteins Rattus norvegicus Rattus rattus. e76 Mouse serum proteins Mus musculus (Mus spp.). e77 Budgerigar droppings Melopsittacus undulatus. e78 Budgerigar feathers Melopsittacus undulatus. e79 Budgerigar serum proteins Melopsittacus undulatus. e80 Goat epithelium Capra hircus. e81 Sheep epithelium Ovis aries (Ovis spp.). e82 Rabbit epithelium Oryctolagus cuniculus (Oryctolagus spp.). e83 Swine epithelium Sus scrofa (Sus scrofa domesticus; Sus spp.). e84 Hamster epithelium Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. e85 Chicken feathers Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86 Duck feathers Anas platyrhynchos. e87 Rat epithelium, serum proteins, and urine proteins Rattus norvegicus Rattus rattus. e88 Mouse epithelium, serum proteins, and urine proteins (mouse) Mus musculus (Mus spp.). e89 Turkey feathers Meleagris gallopavo. e90 Budgerigar serum proteins, feathers, and droppings Melopsittacus undulatus. e91 Pigeon serum proteins, feathers, and droppings Streptopelia roseogrisea Psittacidae spp. e92 Parrot serum proteins, feathers, and droppings Ara spp. e93 Pigeon serum proteins Streptopelia roseogrisea. e94 Fel d 1.0101 Felis domesticus. a345 Fel d 1 Felis domesticus. e98 Parrot droppings Psittacoidea spp. e101 Can f 1.0101 Canis familiaris (Canis domesticus). a174 Can f 1 Canis familiaris (Canis domesticus). e102 Can f 2.0101 Canis familiaris (Canis domesticus). e196 Parakeet feathers Nymphicus hollandicus. e197 Parakeet droppings Nymphicus hollandicus. e198 Parakeet serum Nymphicus hollandicus. e199 Canary bird serum Serinus canarius. e200 Canary bird droppings Serinus canarius. e201 Canary bird feathers (Canary feathers) Serinus canarius. e202 Reindeer epithelium Rangifer tarandus. e203 Mink epithelium Mustela spp. e204 Bos d 6 Bos domesticus (Bos taurus; Bos spp.). e205 Horse, serum proteins Equus caballus (Equus spp.). e206 Rabbit, serum proteins Oryctolagus cuniculus (Oryctolagus spp.). e208 Chinchilla epithelium Chinchilla laniger. e209 Gerbil epithelium Meriones unguiculatus. e210 Fox epithelium Vulpes vulpes. e211 Rabbit, urine proteins Oryctolagus cuniculus (Oryctolagus spp.). e212 Swine, urine proteins Sus scrofa (Sus scrofa domesticus; Sus spp.). e213 Parrot feathers Ara spp. e214 Finch feathers Lonchura domestica. e215 Pigeon feathers Streptopelia roseogrisea (Streptopelia spp.) Columbia spp. e216 Deer epithelium Dama dama. e217 Ferret epithelium Mustela putorius. e218 Chicken droppings Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219 Chicken, serum proteins Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220 Fel d 2, Cat serum albumin Felis domesticus. e221 Can f 3 Canis familiaris (Canis domesticus) (Dog serum albumin). e222 Swine serum albumin (Sus s PSA) Sus scrofa (Sus scrofa domesticus; Sus spp.). e225 Lovebird feathers Psittacoidea agapomis. e226 Can f 5.0101 Canis familiaris. e227 Equ c 1.0101 Equus caballus. e228 Fel d 4.0101 Felis domesticus. e230 Equ c 3 Equus caballus. Start Printed Page 31997 e231 Mus m 1 Mus musculus. Food f9 Rice Oryza sativa. f12 Pea (green pea) Pisum sativum. f15 White bean Phaseolus vulgaris. f19 Cayenne pepper Capsicum frutescens (Capsicum annum). f21 Sugar cane Saccharum officinarum. f22 Raspberry Rubus idaeus. f26 Pork Sus scrofa (Sus scrofa domesticus; Sus spp.). f29 Watermelon Citrullus lanatus (Citrullus vulgaris). f31 Carrot Daucus carota. f32 Oyster mushroom Pleurotus ostreatus. f33 Orange Citrus sinensis. f35 Potato Solanum tuberosum. f43 Mother's milk Homo sapiens. f44 Strawberry Fragaria vesca (Fragaria spp.). f45 Yeast, baker's Saccharomyces cerevisiae. f46 Pepper, Red Capsicum annuum. f47 Garlic Allium sativum. f48 Onion Allium cepa. f49 Apple Malus x domestica (Malus spp.). f51 Bamboo shoot Phyllostachys pubescens. f52 Cacao/chocolate Theobroma cacao. f54 Sweet potato Ipomoea batatas. f55 Common millet Panicum miliaceum. f56 Foxtail millet Setaria italica. f57 Japanese millet Echinochloa crus-galli. f58 Pacific squid Todarodes pacificus. f59 Octopus Octopus vulgaris (Octopus spp.). f63 Kefir NA. f67 Parmesan cheese NA. f81 Cheese, cheddar type NA. f82 Cheese, mold type NA. f83 Chicken Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86 Parsley Petroselinum crispum. f87 Melon Cucumis melo Cucumis melo + Citrullus lanatus. f88 Mutton (lamb) Ovis aries (Ovis spp.). f90 Malt Hordeum vulgare. f92 Banana Musa spp. f93 Cacao Theobroma cacao. f94 Pear Pyrus communis (Pyrus spp.). f97 Yam Dioscorea spp. Dioscorea opposita. f97 Chamomile tea Matricaria chamomilla. f98 Gliadin Triticum aestivum (Triticum spp.). f102 Cantaloupe Cucumis melo var. cantalupensis. f105 Chocolate Theobroma cacao. f109 Cottonseed Gossypium hirsutum. f110 Giant radish Raphanus sativus. f118 Zucchini Cucurbita pepo. f119 Radish Raphanus sativus. f120 Venison Capreolus capeolus. f121 Pinto bean Phaseolus vulgaris. f122 Cheese, American NA. f127 Black-eyed pea Vigna unguiculata. f131 Black Olive Olea europaea. f136 Red beet Beta vulgaris var. conditiva. f139 Goat's Cheese Capra aegagrus. f140 Bran NA. f141 Corn (vegetables) Zea mays. f152 Green bell pepper Capsicum annuum. f155 Brewer's yeast Saccharomyces carlsbergensis. f157 Duck Anas domesticus. f158 Goose Anser anser. f160 Camembert cheese NA. Start Printed Page 31998 f162 Nectarine Prunus persica var. nucipersica. f163 Kohlrabi Brassica oleracea var. gongylodes. f65 Perch f166 Leek Allium porrum. f170 Cheese (Switzerland) (Swiss cheese) NA. f174 Fig Ficus carica. f177 Cranberry Vaccinium macrocarpon. f179 Raisin Vitis spp. f182 Lima bean Phaseolus lunatus. f198 Flaxseed (bruised grain) Linum usitatissimum. f199 Untreated native milk Bos domesticus (Bos taurus; Bos spp.). f208 Lemon Citrus limon. f209 Grapefruit Citrus paradisi. f210 Pineapple Ananas comosus. f211 Blackberry Rubus fruticosus. f212 Mushroom (champignon) Agaricus hortensis (Agaricus spp.). f213 Rabbit Oryctolagus cuniculus (Oryctolagus spp.). f214 Spinach Spinacia oleracea. f215 Lettuce Lactuca sativa. f216 Cabbage Brassica oleracea var. capitata. f217 Brussels sprouts Brassica oleracea var. gem. f218 Paprika, sweet pepper Capsicum annuum. f219 Fennel seed Foeniculum vulgare. f219 Sage Salvia officinalis. f220 Cinnamon Cinnamomum spp. f221 Coffee Coffea spp. f222 Tea Camellia sinensis. f223 Green olive Olea europaea. f225 Summer squash, pumpkin Cucurbita pepo. f225 Pumpkin Cucurbita maxima. f226 Pumpkin seed Cucurbita pepo. f227 Sugar-beet seed Beta vulgaris. f229 Safflower Seed Carthamus tinctorius. f231 Milk, boiled Bos domesticus (Bos taurus; Bos spp.). f234 Vanilla Vanilla planifolia. f237 Apricot Prunus armeniaca. f241 Gouda cheese NA. f242 Cherry Prunus avium. f244 Cucumber Cucumis sativus. f246 Guar, guar gum Cyamopsis tetragonoloba. f247 Honey NA. f248 Rosemary Rosmarinus officinalis. f254 Plaice Pleuronectes platessa. f255 Plum Prunus domestica Prunus americana. f258 Squid Loligo spp. f259 Grape Vitis vinifera (Vitis spp.). f260 Broccoli Brassica oleracea var. italica (Brassica oleracea var. cultivar). f261 Asparagus Asparagus officinalis. f262 Aubergine, eggplant Solanum melongena. f263 Green pepper Piper nigrum Capsicum annuum. f264 Eel Anguilla anguilla. f265 Caraway Carum carvi. f265 Cumin Cuminum cyminum. f266 Mace Myristica fragrans. f267 Cardamon Elettaria cardamomum. f268 Clove Syzygium aromaticum. f269 Basil Ocimum basilicum. f270 Ginger Zingiber officinale. f271 Anise Pimpinella anisum. f272 Tarragon Artemisia dracunculus. f273 Thyme Thymus vulgaris. f274 Marjoram Origanum majorana. f275 Lovage Levisticum officinale. f276 Fennel, fresh Foeniculum vulgare. Start Printed Page 31999 f277 Dill Anethum graveolens. f278 Bay leaf Laurus nobilis. f279 Chili pepper Capsicum frutescens. f280 Black pepper Piper nigrum. f281 Curry (Santa Maria) NA. f282 Nutmeg Myristica fragrans. f283 Oregano Origanum vulgare. f284 Turkey meat Meleagris gallopavo. f285 Elk/moose meat Alces spp. f286 Mare's milk Equus caballus (Equus spp.). f287 Red kidney bean Phaseolus vulgaris. f288 Blueberry Vaccinium myrtillus (Vaccinium spp.). f289 Date Phoenix dactylifera. f291 Cauliflower Brassica oleracea var. botrytis. f292 Guava Psidium guajava. f293 Papaya Carica papaya. f294 Passion fruit, Maracuja Passiflora edulis (Passiflora spp.). f295 Carambola Averrhoa carambola. f296 Carob Ceratonia siliqua. f297 Gum arabic Acacia senegal (Acacia spp.). f298 Tragacanth Astragalus spp. f299 Sweet chestnut (chestnut) Castanea sativa. f300 Pinto bean Phaseolus spp. f301 Persimmon (kaki fruit, sharon) Diospyros kaki. f302 Mandarin (tangerine, clementine, satsumas) Citrus reticulata. f305 Fenugreek Trigonella foenum-graecum. f306 Lime Citrus aurantifolia. f307 Hake Merluccius merluccius. f308 Sardine (pilchard) Sardina pilchardus. f310 Blue vetch Lathyrus sativus. f311 Megrim Lepidorhombus whiffiagonis. f315 Green bean Phaseolus vulgaris. f316 Rape seed Brassica napus. f317 Coriander Coriandrum sativum. f318 Jack fruit Artocarpus heterophyllus. f319 Beetroot Beta vulgaris. f320 Crayfish Astacus astacus. f321 Horse meat Equus caballus (Equus spp.). f322 Red currant Ribes sylvestre. f324 Hop (fruit cone) Humulus lupulus. f325 Saffron Colchicum autumnale. f328 Fig Ficus carica. f329 Watermelon Citrullus lanatus. f330 Rose hip Rosa spp. f331 Saffron Crocus sativus. f332 Mint Mentha piperita. f333 Linseed Linum usitatissimum. f336 Jujube Ziziphus jujuba. f336 Wine vinegar Vitis vinifera (Vitis spp.). f337 Sole Solea solea. f337 English sole Parophrys vetulus. f338 Wine, white Vitis vinifera (Vitis spp.). f339 Allspice Pimenta dioica. f339 Wine, red Vitis vinifera (Vitis spp.). f341 Cranberry Vaccinium oxycoccus Vaccinium macrocarpon. f342 Olive (black, fresh) Olea europaea. f343 Raspberry Rubus idaeus. f344 Sage Salvia officinalis. f346 Chives Allium schoenoprasum. f347 Quinoa Chenopodium quinoa. f348 Litchi Litchi chinensis. f349 Chum salmon roe Oncorhynchus keta. f358 Artichoke Cynara scolymus. f360 Yogurt NA. f368 Black bass Micropterus dolomieu (Micropterus dolomieui). f374 Karaya gum Sterculia urens. f375 Horseradish Armoracia rusticana. f377 Maple syrup NA. f379 Okra Abelmoschus esculentus. Start Printed Page 32000 f382 Beet, sugar Beta vulgaris var. altissima. f401 Loquat Eriobotrya japonica. f402 Fig Ficus carica. f403 Brewer's yeast Saccharomyces cerevisiae. f405 Mint Mentha spp. f406 Arugula Eruca vesicaria. House Dust h1 Greer Labs., Inc. NA. h2 Hollister-Stier Labs. NA. h6 Japan NA. Venoms & Insects i7 Midge Chironomus yoshimatsui. i8 Moth Bombyx mori Heterocera spp. i47 Water flea Daphnia spp. i49 Deer fly Chrysops spp. i51 Black ant Camponotus pennsylvanicus. i54 Flea mix (dog/cat), common flea Ctenocephalides spp. i71 Mosquito Aedes communis Aedes spp. and Culex spp. i72 Green nimitti Cladotanytarsus lewisi. i73 Blood worm Chironomus thummi Chironomusri parius Chironomus spp. i75 European hornet Vespa crabro. i76 Berlin beetle Trogoderma angustum. i77 European paper wasp Polistes dominulus. i78 Fly Musca domestica. i80 Bumblebee Bombus pennsylvanicus. i201 Horse bot fly Gasterophilus intestinalis. i202 Grain weevil Sitophilus granarius. i203 Mediterranean flour moth Ephestia kuehniella (Anagasta kuehniella). i204 Horse fly Tabanus spp. i205 Bumblebee Bombus terrestris. i208 Api m 1.0101 Apis mellifera. a45 Api m 1 Apis mellifera. i209 Ves v 5.0101 Vespula vulgaris. a670 Ves v 5 Vespula vulgaris. i210 Pol d 5.0101 Polistes dominulus. i211 Ves v 1.0101 Vespula vulgaris. i213 Api m 4 Apis mellifera. i214 Api m 2 Apis mellifera. i215 Api m 3 Apis mellifera. i216 Api m 5 Apis mellifera. i217 Api m 10 Apis mellifera. i220 Bla g 1.0101 Blattella germanica. i221 Bla g 2.0101 Blattella germanica. i222 Bla g 5.0101 Blattella germanica. i223 Bla g 7 Blattella germanica a46 Api m 2 Apis mellifera. Miscellaneous o1 Cotton, crude fibers Gossypium spp. o3 Cotton (treated) Gossypium spp. o70 Seminal fluid Homo sapiens. o71 Staphylococcus aureus Staphylococcus aureus. o72 Pichia pastoris crude extract customer specific Pichia pastoris. o72 Sperm-sediment Homo sapiens. o73 Pichia pastoris crude extr. vector customer specific Pichia pastoris. o74 Pichia pastoris with vector customer specific Pichia pastoris. o201 Tobacco leaf, tobacco dust Nicotiana tabacum. o202 Artemia salina, fish feed Artemia salina. o203 Tetramin, fish feed NA. o207 Daphnia, fish feed Daphnia spp. o211 Mealworm Tenebrio molitor. Start Printed Page 32001 o212 Streptavidin Streptomyces avidini. o213 MBP (maltose binding protein) Escherichia coli. o214 CCD; MUXF3 from bromelain Ananas comosus. o72 Enterotoxin A (Sta a SEA) Staphylococcus aureus. o73 Enterotoxin B (Sta a SEB) Staphylococcus aureus. Parasites p1 Ascaris Ascaris suum. p2 Echinococcus Echinococcus granulosus. p3 Schistosoma Schistosoma mansoni. p4 Anisakis (Herring Worm) Anisakis simplex (Anisakis spp.). p5 Toxocara canis Toxocara canis. p10 Ani s 3.0101 Anisakis simplex (Anisakis spp.). p11 Ani s 1 Anisakis simplex (Anisakis spp.). Occupational k4 Threshing dust NA. k5 Flax NA. k7 Hay Dust NA. k8 Hop (hops) Humulus lupulus. k12 Grain mill dust NA. k14 Kapok NA. k20 Sheep's wool (treated) (wool) Ovis aries (Ovis spp.). k21 Sheep's wool (Untreated) Ovis aries (Ovis spp.). k23 Straw Dust NA. k33 Oak NA. k70 Green coffee bean Coffea spp. k71 Castor bean Ricinus communis. k72 Ispaghula Plantago psyllium/Plantago ovata. k73 Silk waste NA. k74 Silk Bombyx mori. k75 Isocyanate TDI (Toluene diisocyanate) NA. k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA. k77 Isocyanate HDI (Hexamethylen diisocyanate) NA. k78 Ethylene oxide NA. k79 Phthalic anhydride NA. k80 Formaldehyde/Formalin NA. k81 Ficus Ficus benjamina (Ficus spp.). k83 Cotton seed Gossypium hirsutum. k84 Sunflower seed Helianthus annuus. k85 Chloramin T NA. k86 Trimellitic anhydride, TMA NA. k87 Asp o 21, alpha-amylase Aspergillus oryzae. k89 Orris root Iris florentina. k99 HSA (Human Serum Albumin) (Hom s HSA) Homo sapiens. k201 Car p 1, Papain Carica papaya. k202 Ana c 2, Bromelain Ananas comosus. k204 Maxatase Bacillus licheniformis. k205 Alcalase Bacillus spp. k206 Savinase, Protease 1 (Bac l Subtilisin) Bacillus spp. k208 Gal d 4, Lysozyme Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 Hexahydrophtalic anhydrid NA. k210 Maleic anhydride NA. k211 Methyltetrahydrophtalic anhydrid NA. k212 Abachi wood dust Triplochiton scleroxylon. k213 Pepsin (Sus s Pepsin) Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 TCPA NA. k214 Bougainvillea Bougainvillea spp. k225 Horse radish peroxidase (Arm r HRP) Armoracia rusticana. k226 Ascorbate oxidase (Cuc p ascorbate oxidase) Cucurbita pepo. k301 Flour dust Triticum spp. k501 Savinase customer specific Proprietary knowledge of customer. k502 Lipolase customer specific Proprietary knowledge of customer. k503 Termamyl customer specific Proprietary knowledge of customer. k504 Clazinase customer specific Proprietary knowledge of customer. V. Reference
The following reference is on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.
1. FDA Guidance, “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
Start SignatureEnd Signature End Supplemental InformationDated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14453 Filed 7-10-17; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Published:
- 07/11/2017
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 2017-14453
- Pages:
- 31976-32002 (27 pages)
- Docket Numbers:
- Docket No. FDA-2017-N-1129
- PDF File:
- 2017-14453.pdf
- Supporting Documents:
- » Attachment 9 Becker, E. High Resolution NMR (Third Edition) Theory and Chemical Applications Table of Contents re: Comment from Bruker
- » Attachment 8 Becker, E. A Brief History of Nuclear Magnetic Resonance Anal Chemistry, 65, 6, (1993) re: Comment from Bruker
- » Attachment 7 History of Bruker re: Comment from Bruker
- » Attachment 2 Beger et al Metabolomics enables precision medicine: "A White Paper, Community Perspective" Metabolomics (20 16) I 2:149 re: Comment from Bruker
- » Attachment 1 Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines and Blood Products: NMR Spectroscopy and Light Scattering re: Comment from Bruker
- » Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff re: Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments