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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 July 08, 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.


Immunology

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
866.4750 Automated indirect immunofluorescence microscope and software-assisted system.    
  PIV -  Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use II
866.5080 Alpha-1-antichymotrypsin immunological test system.    
  DFF -  Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control II
866.5090 Antimitochondrial antibody immunological test system.    
  DBM -  Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control II
  NRI -  Autoantibodies, Nuclear Pore Glycoprotein Gp210 II
  NUM -  Autoantibodies, Nuclear Body Protein, Sp100 II
866.5100 Antinuclear antibody immunological test system.    
  DHN -  Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control II
  KTL -  Anti-Dna Indirect Immunofluorescent Solid Phase II
  LJM -  Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls II
  LKJ -  Antinuclear Antibody, Antigen, Control II
  LKO -  Anti-Rnp Antibody, Antigen And Control II
  LKP -  Anti-Sm Antibody, Antigen And Control II
  LLL -  Extractable Antinuclear Antibody, Antigen And Control II
  LRM -  Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control II
  LSW -  Anti-Dna Antibody, Antigen And Control II
  MQA -  Anti-Ribosomal P Antibodies II
  NYO -  Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody II
  OBE -  Anti-Ss-A 52 Autoantibodies II
  PET -  Anti-Ss-A Ro60 Autoantibodies II
866.5110 Antiparietal antibody immunological test system.    
  DBJ -  Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control II
  MLE -  Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control II
866.5120 Antismooth muscle antibody immunological test system.    
  DBE -  Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control II
  NJF -  Antibodies, Anti-Actin, Anti-Smooth Muscle II
866.5130 Alpha-1-antitrypsin immunological test system.    
  DEI -  Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control II
  DEM -  Alpha-1-Antitrypsin, Antigen, Antiserum, Control II
  DFB -  Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control II
  OBZ -  Alpha-1-Antitrypsin Kit, Qualitative Phenotype II
  PZH -  Serpina1 Variant Detection System II
866.5150 Bence-Jones proteins immunological test system.    
  CZQ -  Bence-Jones Protein, Antigen, Antiserum, Control II
  JKM -  Immunochemical, Bence-Jones Protein II
866.5180 Fecal calprotectin immunological test system.    
  NXO -  Calprotectin, Fecal II
866.5240 Complement components immunological test system.    
  CZW -  Complement C3, Antigen, Antiserum, Control II
  CZY -  Complement C1s, Antigen, Antiserum, Control II
  DAE -  Complement C9, Antigen, Antiserum, Control II
  DAG -  Complement C8, Antigen, Antiserum, Control II
  DAI -  Complement C1r, Antigen, Antiserum, Control II
  DAK -  Complement C1q, Antigen, Antiserum, Control II
  DAY -  Complement C5, Antigen, Antiserum, Control II
  DBI -  Complement C4, Antigen, Antiserum, Control II
  KTM -  C3-Indirect Immunofluorescent Solid Phase II
866.5250 Complement C1 inhibitor (inactivator) immunological test system.    
  DBA -  Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control II
866.5260 Complement C3b inactivator immunological test system.    
  DAC -  Complement C3b Activator, Antigen, Antiserum, Control II
  KTP -  Complement C3b Activator Immunoassay Reagents II
866.5270 C-reactive protein immunological test system.    
  DCH -  System, Test, C-Reactive Protein, Rhodamine II
  DCK -  C-Reactive Protein, Antigen, Antiserum, And Control II
  DCN -  System, Test, C-Reactive Protein II
  NQD -  Cardiac C-Reactive Protein, Antigen, Antiserum, And Control II
866.5340 Ferritin immunological test system.    
  JMG -  Radioimmunoassay (Two-Site Solid Phase), Ferritin II
  DBF -  Ferritin, Antigen, Antiserum, Control II
866.5350 Fibrinopeptide A immunological test system.    
  DAN -  Fibrinopeptide A, Antigen, Antiserum, Control II
866.5500 Hypersensitivity pneumonitis immunological test system.    
  DGW -  System, Test, Hypersensitivity Pneumonitis II
866.5510 Immunoglobulins A, G, M, D, and E immunological test system.    
  CFF -  Immunoelectrophoretic, Immunoglobulins, (G, A, M) II
  CFN -  Method, Nephelometric, Immunoglobulins (G, A, M) II
  CFQ -  Radioimmunoassay, Immunoglobulins (G, A, M) II
  CGM -  Method, Immunodiffusion, Immunoglobulins (G, A, M) II
  CZJ -  Igd, Antigen, Antiserum, Control II
  CZK -  Iga, Rhodamine, Antigen, Antiserum, Control II
  CZL -  Iga, Peroxidase, Antigen, Antiserum, Control II
  CZM -  Iga, Ferritin, Antigen, Antiserum, Control II
  CZN -  Iga, Fitc, Antigen, Antiserum, Control II
  CZP -  Iga, Antigen, Antiserum, Control II
  DAF -  Gamma Globulin, Fitc, Antigen, Antiserum, Control II
  DAH -  Gamma Globulin, Antigen, Antiserum, Control II
  DEW -  Igg, Antigen, Antiserum, Control II
  DFM -  Ige, Ferritin, Antigen, Antiserum, Control II
  DFO -  Igg, Rhodamine, Antigen, Antiserum, Control II
  DFZ -  Igg (Gamma Chain Specific), Antigen, Antiserum, Control II
  DGC -  Ige, Antigen, Antiserum, Control II
  DGD -  Igg, Ferritin, Antigen, Antiserum, Control II
  DGE -  Igd, Rhodamine, Antigen, Antiserum, Control II
  DGG -  Igd, Fitc, Antigen, Antiserum, Control II
  DGK -  Igg, Fitc, Antigen, Antiserum, Control II
  DGL -  Ige, Rhodamine, Antigen, Antiserum, Control II
  DGP -  Ige, Fitc, Antigen, Antiserum, Control II
  JHR -  Radioimmunoassay, Immunoglobulins (D, E) II
  KTS -  Second Antibody (Species Specific Anti-Animal Gamma Globulin) II
  MLH -  Strip, Hama Igg, Elisa, In Vitro Test System II
  OPX -  Immunoglobulin A Kappa Heavy & Light Chain Combined II
  OPY -  Igal Heavy & Light Chain Combined II
  PCN -  Immunoglobulin G Kappa Heavy And Light Chain Combined II
  PCO -  Immunoglobulin G Lambda Heavy And Light Chain Combined II
  PDE -  Immunoglobulin M Kappa Heavy And Light Chain Combined II
  PDF -  Immunoglobulin M Lambda Heavy And Light Chain Combined II
  DAA -  Igg, Peroxidase, Antigen, Antiserum, Control II
  DGH -  Igd, Peroxidase, Antigen, Antiserum, Control II
  DGO -  Ige, Peroxidase, Antigen, Antiserum, Control II
866.5550 Immunoglobulin (light chain specific) immunological test system.    
  DAO -  Igm (Mu Chain Specific), Antigen, Antiserum, Control II
  DEH -  Lambda, Antigen, Antiserum, Control II
  DEK -  Kappa, Rhodamine, Antigen, Antiserum, Control II
  DEO -  Kappa, Fitc, Antigen, Antiserum, Control II
  DES -  Lambda, Fitc, Antigen, Antiserum, Control II
  DEZ -  Igm, Rhodamine, Antigen, Antiserum, Control II
  DFG -  Lambda, Rhodamine, Antigen, Antiserum, Control II
  DFH -  Kappa, Antigen, Antiserum, Control II
  DFL -  Igm, Ferritin, Antigen, Antiserum, Control II
  DFS -  Igm, Fitc, Antigen, Antiserum, Control II
  DFT -  Igm, Antigen, Antiserum, Control II
  DEP -  Lambda, Peroxidase, Antigen, Antiserum, Control II
  DEY -  Igm, Peroxidase, Antigen, Antiserum, Control II
  DFD -  Kappa, Peroxidase, Antigen, Antiserum, Control II
  LYE -  Cytokeratins II
866.5580 Alpha-1-lipoprotein immunological test system.    
  DER -  Alpha-1-Lipoprotein, Antigen, Antiserum, Control II
866.5600 Low-density lipoprotein immunological test system.    
  DFC -  Lipoprotein, Low-Density, Antigen, Antiserum, Control II
  NOE -  Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 II
  NTV -  Myeloperoxidase, Immunoassay, System, Test II
866.5640 Infectious mononucleosis immunological test system.    
  KTN -  System, Test, Infectious Mononucleosis II
866.5660 Multiple autoantibodies immunological test system.    
  DBL -  Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control II
  MID -  System, Test, Anticardiolipin Immunological II
  MOB -  Test System, Antineutrophil Cytoplasmic Antibodies (Anca) II
  MSV -  System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) II
  MVJ -  Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) II
  MVM -  Autoantibodies, Endomysial(Tissue Transglutaminase) II
  NBO -  Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) II
  NBS -  Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) II
  NIY -  Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis II
  NST -  Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking II
  NWG -  Autoantibodies, Glutamic Acid Decarboxylase (Gad) II
  OCN -  Insulin Autoantibody Kit II
  OEG -  Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 II
  OIF -  Tyrosine Phosphatase (Ia-2) Autoantibody Assay II
  OPN -  Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex II
  OSK -  Anti-Glutamate Receptor (Type Nmda) Ifa II
  PAF -  Voltage Gated Calcium Channel (Vgcc) Antibody Assay II
  PCG -  21-Hydroxylase Antibody (21-Ohab) II
866.5665 Aquaporin-4 autoantibody immunological test system.    
  PNI -  Aquaporin-4 Autoantibody II
866.5670 Zinc transporter 8 autoantibody immunological test system.    
  PHF -  Zinc Transporter 8 Auto-Antibody II
866.5680 Myoglobin immunological test system.    
  DDO -  Myoglobin, Rhodamine, Antigen, Antiserum, Control II
  DDR -  Myoglobin, Antigen, Antiserum, Control II
  DEA -  Myoglobin, Fitc, Antigen, Antiserum, Control II
  MVE -  Biosensor, Immunoassay, Myoglobin II
866.5750 Radioallergosorbent (RAST) immunological test system.    
  DHB -  System, Test, Radioallergosorbent (Rast) Immunological II
  MST -  Antibodies, Gliadin II
866.5760 Tryptase test system.    
  OYL -  Tryptase Assay System II
866.5775 Rheumatoid factor immunological test system.    
  DHR -  System, Test, Rheumatoid Factor II
  NHX -  Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) II
  NPH -  Antigen, Cartilage Oligomeric Matrix Protein (Comp) II
  OQZ -  Anti-Mutated Citrullinated Vimentin Igg II
866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.    
  NBT -  Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) II
  OKM -  Antibodies, Outer-Membrane Proteins II
866.5820 Systemic lupus erythematosus immunological test system.    
  DHC -  System, Test, Systemic Lupus Erythematosus II
  NRX -  Complement 4d (C4d) And Complement Receptor 1 (Cr1) II
866.5830 Brain trauma assessment test.    
  QAT -  Brain Trauma Assessment Test II
866.5870 Thyroid autoantibody immunological test system.    
  DDC -  Thyroglobulin, Antigen, Antiserum, Control II
  DDJ -  Thyroglobulin, Fitc, Antigen, Antiserum, Control II
  DDL -  Thyroglobulin, Rhodamine, Antigen, Antiserum, Control II
  JNL -  Immunochemical, Thyroglobulin Autoantibody II
  JZO -  System, Test, Thyroid Autoantibody II
866.5880 Transferrin immunological test system.    
  DDD -  Transferrin, Rhodamine, Antigen, Antiserum, Control II
  DDG -  Transferrin, Antigen, Antiserum, Control II
  DDI -  Transferrin, Fitc, Antigen, Antiserum, Control II
  JNM -  Immunochemical, Transferrin II
866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).    
  PJI -  Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System II
866.6010 Tumor-associated antigen immunological test system.    
  LOQ -  Device, General Purpose, Hematology II
  DHX -  System, Test, Carcinoembryonic Antigen II
  LOJ -  Kit, Test,Alpha-Fetoprotein For Testicular Cancer II
  LTJ -  Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers II
  LTK -  Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) II
  MMW -  System, Test, Tumor Marker, Monitoring, Bladder II
  MOI -  System, Test, Immunological, Antigen, Tumor II
  MSW -  System, Test, Thyroglobulin II
  MUT -  Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer) II
  NCW -  System, Test, Her-2/Neu, Monitoring II
  NIG -  System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer II
  NTY -  System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer II
  NVA -  Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma II
  OIU -  Test, Epithelial Ovarian Tumor Associated Antigen (He4) II
  OVK -  Cytokeratin Fragments 21-1 Eia Kit II
  OXP -  Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment II
866.6030 AFP-L3% immunological test system.    
  NSF -  Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment II
  OAU -  Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma II
866.6040 Gene expression profiling test system for breast cancer prognosis.    
  OVQ -  Chronic Lymphocytic Leukemia Fish Probe Kit II
  OWK -  Early Growth Response 1 (Egr) Fish Probe Kit II

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