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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 November 29, 2021

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

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