2017-04938. Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.

DATES:

Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-1129 for “Medical Devices; Exemptions from Premarket Notification: Class II Devices.” Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR 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, 301-348-1446, email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.

Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.

On December 13, 2016, the President signed into law the 21st Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires FDA to 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 to provide reasonable assurance of safety and effectiveness. FDA is required to publish this notice within 90 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. 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 exemption of the devices that were contained in the present list published under section 510(m)(1)(A) of the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

In a final action, and after considering comments, FDA intends to amend the codified language for each listed regulation to reflect the final determination with respect to exempt devices. FDA's final action 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 510(k) 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 guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1).

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 initial 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 §§ 862.9 to 892.9) 21 CFR 862.9 to 892.9, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA is listing the exemption of the endoscopic magnetic retriever, but limits the exemption to such devices that are for single use. All other endoscopic magnetic retrievers are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.

IV. List of Class II Devices

FDA is identifying the following list of class II devices that, if finalized, would 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:

Table 1—Class II Devices

21 CFR section	Device type	Product code	Partial exemption limitation (if applicable)
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
862.3100	Enzyme Immunoassay, Amphetamine	DKZ	Exemption is limited to test systems intended for 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	DJP	Exemption is limited to test systems intended for 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	DIT	Exemption is limited to test systems intended for 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	DOD	Exemption is limited to test systems intended for 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	DNI	Exemption is limited to test systems intended for 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	DJL	Exemption is limited to test systems intended for 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	DIS	Exemption is limited to test systems intended for 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	Radioimmunoassay, Barbiturate	DKN	Exemption is limited to test systems intended for 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	DKX	Exemption is limited to test systems intended for 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	DJN	Exemption is limited to test systems intended for 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	DLX	Exemption is limited to test systems intended for 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	DMF	Exemption is limited to test systems intended for 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	KZY	Exemption is limited to test systems intended for 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	JXM	Exemption is limited to test systems intended for 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	LAA	Exemption is limited to test systems intended for 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	Test, Benzodiazepine, Over The Counter	NFV	Exemption is limited to test systems intended for 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	KZZ	Exemption is limited to test systems intended for 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	LAB	Exemption is limited to test systems intended for 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.).
862.3200	Calibrators, Drug Mixture	DKB
862.3200	Calibrators, Drug Specific	DLJ
862.3200	Calibrators, Ethyl Alcohol	DNN
862.3250	Enzyme Immunoassay, Cocaine and Cocaine Metabolites	DIO	Exemption is limited to test systems intended for 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	KLN	Exemption is limited to test systems intended for 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	JXO	Exemption is limited to test systems intended for 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)	DLN	Exemption is limited to test systems intended for 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	DMN	Exemption is limited to test systems intended for 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	Free Radical Assay, Cocaine	DIR	Exemption is limited to test systems intended for 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	DIN	Exemption is limited to test systems intended for 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	DOM	Exemption is limited to test systems intended for 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	LAC	Exemption is limited to test systems intended for 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	LAE	Exemption is limited to test systems intended for 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	DLD	Exemption is limited to test systems intended for 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	LAD	Exemption is limited to test systems intended for 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)	DLB	Exemption is limited to test systems intended for 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	Free Radical Assay, LSD	DOL	Exemption is limited to test systems intended for 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	LAF	Exemption is limited to test systems intended for 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	DJC	Exemption is limited to test systems intended for 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	LAG	Exemption is limited to test systems intended for 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	NGG	Exemption is limited to test systems intended for 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	DJR	Exemption is limited to test systems intended for 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	DIW	Exemption is limited to test systems intended for 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	DMB	Exemption is limited to test systems intended for 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	Thin Layer Chromatography, Methadone	DKR	Exemption is limited to test systems intended for 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	DNT	Exemption is limited to test systems intended for 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	DPP	Exemption is limited to test systems intended for 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	KXS	Exemption is limited to test systems intended for 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	DNK	Exemption is limited to test systems intended for 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.	DOE	Exemption is limited to test systems intended for 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	DJJ	Exemption is limited to test systems intended for 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	DPK	Exemption is limited to test systems intended for 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	Gas Chromatography, Morphine	DMY	Exemption is limited to test systems intended for 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	DLR	Exemption is limited to test systems intended for 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	DOK	Exemption is limited to test systems intended for 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.	DIQ	Exemption is limited to test systems intended for 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	DNA	Exemption is limited to test systems intended for 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	DJG	Exemption is limited to test systems intended for 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	DJF	Exemption is limited to test systems intended for 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	DLT	Exemption is limited to test systems intended for 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	Thin Layer Chromatography, Opiates	LAI	Exemption is limited to test systems intended for 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	DKT	Exemption is limited to test systems intended for 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	LAH	Exemption is limited to test systems intended for 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	JXN	Exemption is limited to test systems intended for 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	DPN	Exemption is limited to test systems intended for 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	LAJ	Exemption is limited to test systems intended for 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	LAK	Exemption is limited to test systems intended for 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	LDJ	Exemption is limited to test systems intended for 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	Reagents, Test, Tetrahydrocannabinol	DKE	Exemption is limited to test systems intended for 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)	LAT	Exemption is limited to test systems intended for 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	LFI	Exemption is limited to test systems intended for 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	LFH	Exemption is limited to test systems intended for 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	MLK	Exemption is limited to test systems intended for 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.).
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
866.5750	System, Test, Radioallergosorbent (RAST) Immunological	DHB	Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 2 of this document.
866.5910	Quality Control Material, Genetics, DNA	NZB
868.1040	Algesimeter, Powered	BSI
868.1400	Legging, Compression, Non-Inflatable	LLK
868.2385	Analyzer, Nitrogen Dioxide	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.
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
870.1330	Wire, Guide, Catheter	DQX	Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires.
870.1390	Trocar	DRC
870.1650	Syringe, Balloon Inflation	MAV	Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.
870.1875	Lung Sound Monitor	OCR
870.2675	Oscillometer	DRZ
870.2770	Analyzer, Body Composition	MNW	Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
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
870.4400	Reservoir, Blood, Cardiopulmonary Bypass	DTN	Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.
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
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
874.1090	Tester, Auditory Impedance	ETY	Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
874.1090	Tympanometer	NAS	Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
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	Endoscopic Magnetic Retriever	FCC	Exemption is limited to endoscopic magnetic retrievers intended for single use.
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	Scissors For Cystoscope	KGD	Exemption is limited to sterile scissors for cystoscope intended for single use.
876.1500	LED Light Source	NTN
876.1500	Endoscopic Guide Wire, Gastroenterology-Urology	OCY
876.1500	Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use.
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
876.5010	Catheter, Biliary, Surgical	GCA	Exemption is limited to surgical biliary catheters that do not include a balloon component.
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
876.5630	Catheter, Peritoneal, Long-Term Indwelling	FJS	Exemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630	Catheter, Peritoneal Dialysis, Single Use	FKO	Exemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630	System, Peritoneal, Automatic Delivery	FKX	Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales.
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
878.4370	Drape, Surgical	KKX	Exemption is limited to surgical drapes that do not include an antimicrobial agent.
878.4495	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs.
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
882.1470	Computerized Cognitive Assessment Aid	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.
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
884.1630	Colposcope (and Colpomicroscope)	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.
884.2990	Sheet, Recording, Breast Examination	NHM
884.3200	Drain, Cervical	HFL
884.4400	Forceps, Obstetrical	HDA
884.4530	Tenaculum, Uterine	HDC	Exemption is limited to sterile urterine tenaculum devices that do not use suction and are intended for single use.
884.4530	Clamp, Umbilical	HFW
884.4530	Speculum, Vaginal, Nonmetal	HIB
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
884.6120	Accessory, Assisted Reproduction	MQG	Exemption is limited to single 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)	MQH	Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass.
884.6150	Micromanipulators and Microinjectors, Assisted Reproduction	MQJ
884.6160	Labware, Assisted Reproduction	MQK	Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.
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
886.1850	Biomicroscope, Slit-Lamp, AC-Powered	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.
886.1945	Transilluminator, AC-Powered	HJM
886.3320	Ocular Peg	MQU	Exemption is limited to ocular pegs supplied sterile.
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 1, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system, product code “DHB”). FDA does not believe that all devices with the product code DHB meet the exemption criteria from premarket notification requirements. However, FDA is identifying a substantial amount of these devices for exemption in table 2.

Table 2—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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Division of Dockets Management (see ADDRESSES) 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.

Dated: March 8, 2017.

Leslie Kux,

Associate Commissioner for Policy.