Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES  


Subpart A — General Provisions
§ 866.1 Scope.
§ 866.3 Effective dates of requirement for premarket approval.
§ 866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B — Diagnostic Devices
§ 866.1620 Antimicrobial susceptibility test disc.
§ 866.1640 Antimicrobial susceptibility test powder.
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
§ 866.1700 Culture medium for antimicrobial susceptibility tests.
Subpart C — Microbiology Devices
§ 866.2050 Staphylococcal typing bacteriophage.
§ 866.2120 Anaerobic chamber.
§ 866.2160 Coagulase plasma.
§ 866.2170 Automated colony counter.
§ 866.2180 Manual colony counter.
§ 866.2190 Automated image assessment system for microbial colonies on solid culture media.
§ 866.2300 Multipurpose culture medium.
§ 866.2320 Differential culture medium.
§ 866.2330 Enriched culture medium.
§ 866.2350 Microbiological assay culture medium.
§ 866.2360 Selective culture medium.
§ 866.2390 Transport culture medium.
§ 866.2410 Culture medium for pathogenic Neisseria spp.
§ 866.2420 Oxidase screening test for gonorrhea.
§ 866.2440 Automated medium dispensing and stacking device.
§ 866.2450 Supplement for culture media.
§ 866.2480 Quality control kit for culture media.
§ 866.2500 Microtiter diluting and dispensing device.
§ 866.2540 Microbiological incubator.
§ 866.2560 Microbial growth monitor.
§ 866.2580 Gas-generating device.
§ 866.2600 Wood's fluorescent lamp.
§ 866.2660 Microorganism differentiation and identification device.
§ 866.2680 Streptococcus spp. nucleic acid-based assay.
§ 866.2850 Automated zone reader.
§ 866.2900 Microbiological specimen collection and transport device.
Subpart D — Serological Reagents
§ 866.3010 Acinetobacter calcoaceticus serological reagents.
§ 866.3020 Adenovirus serological reagents.
§ 866.3035 Arizona spp. serological reagents.
§ 866.3040 Aspergillus spp. serological reagents.
§ 866.3050 Beta-glucan serological assays.
§ 866.3060 Blastomyces dermatitidis serological reagents.
§ 866.3065 Bordetella spp. serological reagents.
§ 866.3085 Brucella spp. serological reagents.
§ 866.3110 Campylobacter fetus serological reagents.
§ 866.3120 Chlamydia serological reagents.
§ 866.3125 Citrobacter spp. serological reagents.
§ 866.3130 Clostridium difficile toxin gene amplification assay.
§ 866.3135 Coccidioides immitis serological reagents.
§ 866.3140 Corynebacterium spp. serological reagents.
§ 866.3145 Coxsackievirus serological reagents.
§ 866.3165 Cryptococcus neoformans serological reagents.
§ 866.3175 Cytomegalovirus serological reagents.
§ 866.3200 Echinococcus spp. serological reagents.
§ 866.3205 Echovirus serological reagents.
§ 866.3210 Endotoxin assay.
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
§ 866.3220 Entamoeba histolytica serological reagents.
§ 866.3225 Enterovirus nucleic acid assay.
§ 866.3235 Epstein-Barr virus serological reagents.
§ 866.3240 Equine encephalomyelitis virus serological reagents.
§ 866.3250 Erysipelothrix rhusiopathiae serological reagents.
§ 866.3255 Escherichia coli serological reagents.
§ 866.3270 Flavobacterium spp. serological reagents.
§ 866.3280 Francisella tularensis serological reagents.
§ 866.3290 Gonococcal antibody test (GAT).
§ 866.3300 Haemophilus spp. serological reagents.
§ 866.3305 Herpes simplex virus serological assays.
§ 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
§ 866.3310 Hepatitis A virus (HAV) serological assays.
§ 866.3320 Histoplasma capsulatum serological reagents.
§ 866.3328 Influenza virus antigen detection test system.
§ 866.3330 Influenza virus serological reagents.
§ 866.3332 Reagents for detection of specific novel influenza A viruses.
§ 866.3336 John Cunningham Virus serological reagents.
§ 866.3340 Klebsiella spp. serological reagents.
§ 866.3350 Leptospira spp. serological reagents.
§ 866.3355 Listeria spp. serological reagents.
§ 866.3360 Lymphocytic choriomeningitis virus serological reagents.
§ 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
§ 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
§ 866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
§ 866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
§ 866.3373 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
§ 866.3375 Mycoplasma spp. serological reagents.
§ 866.3380 Mumps virus serological reagents.
§ 866.3390 Neisseria spp. direct serological test reagents.
§ 866.3395 Norovirus serological reagents.
§ 866.3400 Parainfluenza virus serological reagents.
§ 866.3402 Plasmodium species antigen detection assays.
§ 866.3405 Poliovirus serological reagents.
§ 866.3410 Proteus spp. (Weil-Felix) serological reagents.
§ 866.3415 Pseudomonas spp. serological reagents.
§ 866.3460 Rabiesvirus immunofluorescent reagents.
§ 866.3470 Reovirus serological reagents.
§ 866.3480 Respiratory syncytial virus serological reagents.
§ 866.3490 Rhinovirus serological reagents.
§ 866.3500 Rickettsia serological reagents.
§ 866.3510 Rubella virus serological reagents.
§ 866.3520 Rubeola (measles) virus serological reagents.
§ 866.3550 Salmonella spp. serological reagents.
§ 866.3600 Schistosoma spp. serological reagents.
§ 866.3630 Serratia spp. serological reagents.
§ 866.3660 Shigella spp. serological reagents.
§ 866.3680 Sporothrix schenckii serological reagents.
§ 866.3700 Staphylococcus aureus serological reagents.
§ 866.3720 Streptococcus spp. exoenzyme reagents.
§ 866.3740 Streptococcus spp. serological reagents.
§ 866.3780 Toxoplasma gondii serological reagents.
§ 866.3820 Treponema pallidum nontreponemal test reagents.
§ 866.3830 Treponema pallidum treponemal test reagents.
§ 866.3850 Trichinella spiralis serological reagents.
§ 866.3860 Trichomonas vaginalis nucleic acid assay.
§ 866.3870 Trypanosoma spp. serological reagents.
§ 866.3900 Varicella-zoster virus serological reagents.
§ 866.3920 Assayed quality control material for clinical microbiology assays.
§ 866.3930 Vibrio cholerae serological reagents.
§ 866.3940 West Nile virus serological reagents.
§ 866.3945 Dengue virus serological reagents.
§ 866.3946 Dengue virus nucleic acid amplification test reagents.
§ 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
§ 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
§ 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
Subpart E — Immunology Laboratory Equipment and Reagents
§ 866.4070 RNA Preanalytical Systems.
§ 866.4100 Complement reagent.
§ 866.4500 Immunoelectrophoresis equipment.
§ 866.4520 Immunofluorometer equipment.
§ 866.4540 Immunonephelometer equipment.
§ 866.4600 Ouchterlony agar plate.
§ 866.4700 Automated fluorescence in situ hybridization (FISH) enumeration systems.
§ 866.4750 Automated indirect immunofluorescence microscope and software-assisted system.
§ 866.4800 Radial immunodiffusion plate.
§ 866.4830 Rocket immunoelectrophoresis equipment.
§ 866.4900 Support gel.
Subpart F — Immunological Test Systems
§ 866.5040 Albumin immunological test system.
§ 866.5060 Prealbumin immunological test system.
§ 866.5065 Human allotypic marker immunological test system.
§ 866.5080 Alpha-1-antichymotrypsin immunological test system.
§ 866.5090 Antimitochondrial antibody immunological test system.
§ 866.5100 Antinuclear antibody immunological test system.
§ 866.5110 Antiparietal antibody immunological test system.
§ 866.5120 Antismooth muscle antibody immunological test system.
§ 866.5130 Alpha-1-antitrypsin immunological test system.
§ 866.5150 Bence-Jones proteins immunological test system.
§ 866.5160 Beta-globulin immunological test system.
§ 866.5170 Breast milk immunological test system.
§ 866.5180 Fecal calprotectin immunological test system.
§ 866.5200 Carbonic anhydrase B and C immunological test system.
§ 866.5210 Ceruloplasmin immunological test system.
§ 866.5220 Cohn fraction II immunological test system.
§ 866.5230 Colostrum immunological test system.
§ 866.5240 Complement components immunological test system.
§ 866.5250 Complement C2 inhibitor (inactivator) immunological test system.
§ 866.5260 Complement C3b inactivator immunological test system.
§ 866.5270 C-reactive protein immunological test system.
§ 866.5320 Properdin factor B immunological test system.
§ 866.5330 Factor XIII, A, S, immunological test system.
§ 866.5340 Ferritin immunological test system.
§ 866.5350 Fibrinopeptide A immunological test system.
§ 866.5360 Cohn fraction IV immunological test system.
§ 866.5370 Cohn fraction V immunological test system.
§ 866.5380 Free secretory component immunological test system.
§ 866.5400 Alpha-globulin immunological test system.
§ 866.5420 Alpha-1-glycoproteins immunological test system.
§ 866.5425 Alpha-2-glycoproteins immunological test system.
§ 866.5430 Beta-2-glycoprotein I immunological test system.
§ 866.5440 Beta-2-glycoprotein III immunological test system.
§ 866.5460 Haptoglobin immunological test system.
§ 866.5470 Hemoglobin immunological test system.
§ 866.5490 Hemopexin immunological test system.
§ 866.5500 Hypersensitivity pneumonitis immunological test system.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
§ 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
§ 866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
§ 866.5560 Lactic dehydrogenase immunological test system.
§ 866.5570 Lactoferrin immunological test system.
§ 866.5580 Alpha-1-lipoprotein immunological test system.
§ 866.5590 Lipoprotein X immunological test system.
§ 866.5600 Low-density lipoprotein immunological test system.
§ 866.5620 Alpha-2-macroglobulin immunological test system.
§ 866.5630 Beta-2-microglobulin immunological test system.
§ 866.5640 Infectious mononucleosis immunological test system.
§ 866.5660 Multiple autoantibodies immunological test system.
§ 866.5665 Aquaporin-4 autoantibody immunological test system.
§ 866.5670 Zinc transporter 8 autoantibody immunological test system.
§ 866.5680 Myoglobin immunological test system.
§ 866.5700 Whole human plasma or serum immunological test system.
§ 866.5715 Plasminogen immunological test system.
§ 866.5735 Prothrombin immunological test system.
§ 866.5750 Radioallergosorbent (RAST) immunological test system.
§ 866.5760 Tryptase test system.
§ 866.5765 Retinol-binding protein immunological test system.
§ 866.5775 Rheumatoid factor immunological test system.
§ 866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
§ 866.5800 Seminal fluid (sperm) immunological test system.
§ 866.5820 Systemic lupus erythematosus immunological test system.
§ 866.5830 Brain trauma assessment test.
§ 866.5860 Total spinal fluid immunological test system.
§ 866.5870 Thyroid autoantibody immunological test system.
§ 866.5880 Transferrin immunological test system.
§ 866.5890 Inter-alpha trypsin inhibitor immunological test system.
§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
§ 866.5910 Quality control material for cystic fibrosis nucleic acid assays.
§ 866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
§ 866.5940 Autosomal recessive carrier screening gene mutation detection system.
§ 866.5950 Genetic health risk assessment system.
Subpart G — Tumor Associated Antigen immunological Test Systems
§ 866.6010 Tumor-associated antigen immunological test system.
§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
§ 866.6030 AFP-L3% immunological test system.
§ 866.6040 Gene expression profiling test system for breast cancer prognosis.
§ 866.6050 Ovarian adnexal mass assessment score test system.
§ 866.6060 BCR-ABL quantitation test.
§ 866.6080 Next generation sequencing based tumor profiling test.

Authority

21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

Source

47 FR 50823, Nov. 9, 1982, unless otherwise noted.

EditorNote

, Nomenclature changes to part 866 appear at 73 FR 35341, June 23, 2008.