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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated June 17, 2024

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that fda has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Microbiology

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
866.1620 Antimicrobial susceptibility test disc.    
  JTN -  Susceptibility Test Discs, Antimicrobial II
  LTX -  Discs, Elution II
866.1640 Antimicrobial susceptibility test powder.    
  JTT -  Susceptibility Test Powders, Antimicrobial II
  JWY -  Manual Antimicrobial Susceptibility Test Systems II
  LIE -  Reagent/Device, Inoculum Calibration II
  LOP -  Solution, Antimicrobial II
  LRG -  Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems II
  LTT -  Panels, Test, Susceptibility, Antimicrobial II
  LTW -  Susceptibility Test Cards, Antimicrobial II
  MYI -  System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies II
866.1700 Culture medium for antimicrobial susceptibility tests.    
  JSO -  Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar II
  JTZ -  Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth II
  LKA -  Culture Media, Antimicrobial Susceptibility Test II
  MJD -  Culture Media, Antimycobacteria, Susceptibility Test II
  MJE -  Culture Media, Antifungal, Susceptibility Test II
866.2050 Staphylococcal typing bacteriophage.    
  OUS -  Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt I
866.2190 Automated image assessment system for microbial colonies on solid culture media.    
  PPU -  Microbial Colony Image Assessment System II
866.2360 Selective culture medium.    
  PQZ -  Gbs Culture Media, Selective And Differential I
866.2390 Transport culture medium.    
  JSL -  Culture Media, Anaerobic Transport I
  JSM -  Culture Media, Non-Propagating Transport I
  JSN -  Culture Media, Propagating Transport I
866.2410 Culture medium for pathogenic Neisseria spp.    
  JTY -  Culture Media, For Isolation Of Pathogenic Neisseria II
866.2560 Microbial growth monitor.    
  MDB -  System, Blood Culturing I
866.2850 Automated zone reader.    
  KZK -  Reader, Zone, Automated I
866.2900 Microbiological specimen collection and transport device.    
  JTW -  System, Transport, Aerobic I
  JTX -  Transport Systems, Anaerobic I
  LIO -  Device, Specimen Collection I
866.3040 Aspergillus spp. serological reagents.    
  NOM -  Antigen, Galactomannan, Aspergillus Spp. I
866.3110 Campylobacter fetus serological reagents.    
  GSP -  Antiserum, Fluorescent, Campylobacter Fetus I
  LQO -  Dna-Reagents, Campylobacter Spp. I
  LQP -  Campylobacter Spp. I
  LYR -  Helicobacter Pylori I
  MSQ -  Test, Urea (Breath Or Blood) I
  OWF -  Immunohistochemical Assay, Helicobacter Pylori I
866.3120 Chlamydia serological reagents.    
  GPT -  Antiserum, Cf, Psittacosis (Chlamydia Group) I
  GPW -  Antigen, Cf, Psittacosis (Chlamydia Group) I
  LJC -  Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) I
  LJP -  Antiserum, Fluorescent, Chlamydia Trachomatis I
  LKH -  Antisera, Immunoperoxidase, Chlamydia Spp. I
  LKI -  Antisera, Fluorescent, Chlamydia Spp. I
  LSK -  Dna-Reagents, Chlamydia I
  MGM -  C. Trachomatis (Chlamydia Group) I
  MKZ -  Dna Probe, Nucleic Acid Amplification, Chlamydia I
866.3175 Cytomegalovirus serological reagents.    
  GQH -  Antigen, Cf (Including Cf Control), Cytomegalovirus II
  GQI -  Antiserum, Cf, Cytomegalovirus II
  LIN -  Antisera, Conjugated Fluorescent, Cytomegalovirus II
  LJO -  Antigen, Iha, Cytomegalovirus II
  LKQ -  Antibody Igm,If, Cytomegalovirus Virus II
  LSO -  Dna-Reagents, Cytomegalovirus II
866.3235 Epstein-Barr virus serological reagents.    
  GNP -  Antiserum, Cf, Epstein-Barr Virus I
  GNQ -  Antigen, Cf (Including Cf Control), Epstein-Barr Virus I
  JRY -  Antiserum, Fluorescent, Epstein-Barr Virus I
  LJN -  Antibody Igm, If, Epstein-Barr Virus I
  LLM -  Test, Antigen, Nuclear, Epstein-Barr Virus I
  LSE -  Epstein-Barr Virus, Other I
  LSF -  Dna-Reagents, Epstein-Barr Virus I
  MCD -  Antigen, Ebv, Capsid I
866.3330 Influenza virus serological reagents.    
  NIA -  Assay, Direct, Nucleic Acid Amplification, Influenza Virus I
866.3370 Mycobacterium tuberculosis immunofluorescent reagents.    
  GRT -  Antiserum, Fluorescent, Mycobacterium Tuberculosis I
  LQF -  Dna-Reagents, Mycobacterium Spp. I
  NDZ -  Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis I
  NJO -  System, Mycolic Acid Analysis, Mycobacterium Tuberculosis I
866.3390 Neisseria spp. direct serological test reagents.    
  GTH -  Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae II
  GTI -  Antisera, Fluorescent, All Groups, N. Meningitidis II
  GTJ -  Antisera, All Groups, N. Meningitidis II
  LIC -  Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae II
  LIR -  Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae II
866.3400 Parainfluenza virus serological reagents.    
  NHZ -  Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus I
866.3480 Respiratory syncytial virus serological reagents.    
  NHY -  Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus I
866.3510 Rubella virus serological reagents.    
  GOJ -  Antisera, Neutralization, Rubella II
  GOK -  Antisera, Hai (Including Hai Control), Rubella II
  GOL -  Antigen, Ha (Including Ha Control), Rubella II
  GOM -  Antisera, Cf, Rubella II
  GON -  Antigen, Cf (Including Cf Control), Rubella II
  LFX -  Enzyme Linked Immunoabsorbent Assay, Rubella II
  LQN -  Latex Agglutination Assay, Rubella II
  LSD -  Rubella, Other Assays II
  LSJ -  Antigen, Rubella, Other II
  OPL -  Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus II
866.3780 Toxoplasma gondii serological reagents.    
  GLZ -  Antigens, If, Toxoplasma Gondii II
  GMM -  Antigens, Iha, Toxoplasma Gondii II
  GMN -  Antigens, Cf, Toxoplasma Gondii II
  LGD -  Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii II
  LJK -  Antisera, If, Toxoplasma Gondii II
  LLA -  Direct Agglutination Test, Toxoplasma Gondii II
  LYF -  Pneumocystis Carinii II
866.3820 Treponema pallidum nontreponemal test reagents.    
  GMP -  Antisera, Control For Nontreponemal Tests II
  GMQ -  Antigens, Nontreponemal, All II
866.3830 Treponema pallidum treponemal test reagents.    
  GMR -  Sera, Reactive And Non-Specific Control, Fta-Abs Test II
  GMS -  Anti-Human Globulin, Fta-Abs Test II
  GMT -  Antigens, Ha, Treponema Pallidum II
  GMW -  Test, Sorbent, Fta-Abs II
  GMX -  Antisera, Fluorescent Antibody For Fta-Abs Test II
  JWL -  Antigen, Treponema Pallidum For Fta-Abs Test II
866.3870 Trypanosoma spp. serological reagents.    
  GND -  Antigen, Iha, T. Cruzi I
  GNE -  Antigen, Latex Agglutination, T. Cruzi I
  GNF -  Antigen, Cf, T. Cruzi I
  LOO -  Reagent, Leishmanii Serological I
  MIU -  Enzyme Linked Immunosorbent Assay, T. Cruzi I
  MIV -  Immunofluorescent Assay, T. Cruzi I
  PIT -  Leishmania Spp. Antigen Detection Assay I
866.3900 Varicella-zoster virus serological reagents.    
  GQW -  Antigen, Cf, (Including Cf Control), Varicella-Zoster II
  GQX -  Antiserum, Cf, Varicella-Zoster II
  LFY -  Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster II
866.3920 Assayed quality control material for clinical microbiology assays.    
  PMN -  Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays II

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