Title 21, Part 866 — Immunology and Microbiology Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Antimicrobial susceptibility test disc.

Antimicrobial susceptibility test powder.

Fully automated short-term incubation cycle antimicrobial susceptibility system.

A cellular analysis system for multiplexed antimicrobial susceptibility testing.

System for detection of microorganisms and antimicrobial resistance using reporter expression.

Culture medium for antimicrobial susceptibility tests.

Staphylococcal typing bacteriophage.

Anaerobic chamber.

Coagulase plasma.

Automated colony counter.

Manual colony counter.

Automated image assessment system for microbial colonies on solid culture media.

Multipurpose culture medium.

Differential culture medium.

Enriched culture medium.

Microbiological assay culture medium.

Selective culture medium.

Transport culture medium.

Culture medium for pathogenic spp.

Oxidase screening test for gonorrhea.

Automated medium dispensing and stacking device.

Supplement for culture media.

Quality control kit for culture media.

Microtiter diluting and dispensing device.

Microbiological incubator.

Microbial growth monitor.

Gas-generating device.

Wood's fluorescent lamp.

Microorganism differentiation and identification device.

nucleic acid-based assay.

Automated zone reader.

Microbiological specimen collection and transport device.

Microbial nucleic acid storage and stabilization device.

serological reagents.

Adenovirus serological reagents.

spp. serological reagents.

spp. serological reagents.

In vitro diagnostic device for spp. detection.

Beta-glucan serological assays.

serological reagents.

spp. serological reagents.

spp. serological reagents.

serological reagents.

Chlamydia serological reagents.

spp. serological reagents.

Clostridium difficile toxin gene amplification assay.

serological reagents.

spp. serological reagents.

Coxsackievirus serological reagents.

serological reagents.

Hepatitis C virus antibody tests.

Nucleic acid-based hepatitis C virus ribonucleic acid tests.

Qualitative hepatitis B virus antigen assays.

Hepatitis B virus antibody assays.

Hepatitis B virus nucleic acid-based assays.

Cytomegalovirus serological reagents.

Quantitative cytomegalovirus nucleic acid tests for transplant patient management.

Cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection.

Quantitative viral nucleic acid test for transplant patient management.

spp. serological reagents.

Echovirus serological reagents.

Endotoxin assay.

Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.

serological reagents.

Enterovirus nucleic acid assay.

Device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections.

Device to detect bacterial protease activity in chronic wound fluid.

Epstein-Barr virus serological reagents.

Device to detect or measure nucleic acid from viruses associated with head and neck cancers.

Equine encephalomyelitis virus serological reagents.

serological reagents.

serological reagents.

spp. serological reagents.

serological reagents.

Gonococcal antibody test (GAT).

spp. serological reagents.

Herpes simplex virus serological assays.

Herpes simplex virus nucleic acid-based assay for central nervous system infections.

Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.

Hepatitis A virus (HAV) serological assays.

serological reagents.

Influenza virus antigen detection test system.

Influenza virus serological reagents.

Reagents for detection of specific novel influenza A viruses.

John Cunningham Virus serological reagents.

spp. serological reagents.

spp. serological reagents.

spp. serological reagents.

Lymphocytic choriomeningitis virus serological reagents.

Mass spectrometer system for clinical use for the identification of microorganisms.

Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

Device to detect and identify microbial nucleic acids by FISH in clinical specimens.

immunofluorescent reagents.

Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.

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.

spp. serological reagents.

Device to detect and identify fungal nucleic acids directly in respiratory specimens.

Clinical mass spectrometry microorganism identification and differentiation system.

Mumps virus serological reagents.

spp. direct serological test reagents.

Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).

Norovirus serological reagents.

Parainfluenza virus serological reagents.

Plasmodium species antigen detection assays.

Poliovirus serological reagents.

spp. (Weil-Felix) serological reagents.

spp. serological reagents.

Rabiesvirus immunofluorescent reagents.

Reovirus serological reagents.

Respiratory syncytial virus serological reagents.

Rhinovirus serological reagents.

Rickettsia serological reagents.

Rubella virus serological reagents.

Rubeola (measles) virus serological reagents.

spp. serological reagents.

spp. serological reagents.

spp. serological reagents.

spp. serological reagents.

serological reagents.

serological reagents.

spp. exoenzyme reagents.

spp. serological reagents.

serological reagents.

nontreponemal test reagents.

treponemal test reagents.

serological reagents.

nucleic acid assay.

spp. serological reagents.

Varicella-zoster virus serological reagents.

Assayed quality control material for clinical microbiology assays.

serological reagents.

Zika virus serological reagents.

West Nile virus serological reagents.

Dengue virus serological reagents.

Dengue virus nucleic acid amplification test reagents.

In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.

Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.

Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.

Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.

Human immunodeficiency virus (HIV) viral load monitoring test.

Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.

Device to detect and identify selected microbial agents that cause acute febrile illness.

Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.

Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.

Respiratory viral panel multiplex nucleic acid assay.

Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

Gastrointestinal microorganism multiplex nucleic acid-based assay.

A multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens.

RNA Preanalytical Systems.

Complement reagent.

Immunoelectrophoresis equipment.

Immunofluorometer equipment.

Immunonephelometer equipment.

Ouchterlony agar plate.

Automated fluorescence hybridization (FISH) enumeration systems.

Automated indirect immunofluorescence microscope and software-assisted system.

Radial immunodiffusion plate.

Rocket immunoelectrophoresis equipment.

Support gel.

Albumin immunological test system.

Prealbumin immunological test system.

Human allotypic marker immunological test system.

-1-antichymotrypsin immunological test system.

Antimitochondrial antibody immunological test system.

Antinuclear antibody immunological test system.

Antiparietal antibody immunological test system.

Antismooth muscle antibody immunological test system.

-1-antitrypsin immunological test system.

Bence-Jones proteins immunological test system.

-globulin immunological test system.

Breast milk immunological test system.

Fecal calprotectin immunological test system.

Carbonic anhydrase B and C immunological test system.

Ceruloplasmin immunological test system.

Cohn fraction II immunological test system.

Colostrum immunological test system.

Complement components immunological test system.

Complement C inhibitor (inactivator) immunological test system.

Complement C inactivator immunological test system.

C-reactive protein immunological test system.

Properdin factor B immunological test system.

Factor XIII, A, S, immunological test system.

Ferritin immunological test system.

Fibrinopeptide A immunological test system.

Cohn fraction IV immunological test system.

Cohn fraction V immunological test system.

Free secretory component immunological test system.

-globulin immunological test system.

-1-glycoproteins immunological test system.

-2-glycoproteins immunological test system.

-2-glycoprotein I immunological test system.

-2-glycoprotein III immunological test system.

Haptoglobin immunological test system.

Hemoglobin immunological test system.

Hemopexin immunological test system.

Hypersensitivity pneumonitis immunological test system.

Immunoglobulins A, G, M, D, and E immunological test system.

Immunoglobulin G (Fab fragment specific) immunological test system.

Immunoglobulin G (Fc fragment specific) immunological test system.

Immunoglobulin G (Fd fragment specific) immunological test system.

Immunoglobulin (light chain specific) immunological test system.

Lactic dehydrogenase immunological test system.

Lactoferrin immunological test system.

-1-lipoprotein immunological test system.

Lipoprotein X immunological test system.

Low-density lipoprotein immunological test system.

-2-macroglobulin immunological test system.

-2-microglobulin immunological test system.

Infectious mononucleosis immunological test system.

Multiple autoantibodies immunological test system.

Aquaporin-4 autoantibody immunological test system.

Zinc transporter 8 autoantibody immunological test system.

Myoglobin immunological test system.

Whole human plasma or serum immunological test system.

Plasminogen immunological test system.

Prothrombin immunological test system.

Radioallergosorbent (RAST) immunological test system.

Tryptase test system.

Retinol-binding protein immunological test system.

Rheumatoid factor immunological test system.

Anti-phospholipase A2 receptor immunological test system.

Anti- () antibody (ASCA) test systems.

Seminal fluid (sperm) immunological test system.

Systemic lupus erythematosus immunological test system.

Brain trauma assessment test.

Total spinal fluid immunological test system.

Thyroid autoantibody immunological test system.

Transferrin immunological test system.

Inter- trypsin inhibitor immunological test system.

Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.

Quality control material for cystic fibrosis nucleic acid assays.

Postnatal chromosomal copy number variation detection system.

Newborn screening test for severe combined immunodeficiency disorder (SCID).

Autosomal recessive carrier screening gene mutation detection system.

Genetic health risk assessment system.

Human leukocyte antigen typing companion diagnostic test.

Inherited nucleotide repeat disorder DNA test.

Whole exome sequencing constituent device.

Tumor-associated antigen immunological test system.

Immunomagnetic circulating cancer cell selection and enumeration system.

AFP-L3% immunological test system.

Gene expression profiling test system for breast cancer prognosis.

Ovarian adnexal mass assessment score test system.

BCR-ABL quantitation test.

Mutation detection test for myeloproliferative neoplasms.

Next generation sequencing based tumor profiling test.

Cancer predisposition risk assessment system.

DNA-based test to measure minimal residual disease in hematological malignancies.