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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.


Hematology

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
864.1860 Immunohistochemistry reagents and kits.    
  MXZ -  Immunohistochemistry Assay, Antibody, Progesterone Receptor II
  MYA -  Immunohistochemistry Antibody Assay, Estrogen Receptor II
  NJW -  Control Material, Her-2/Neu, Immunohistochemistry II
864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.    
  PDO -  Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization II
  PFG -  Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders II
864.5200 Automated cell counter.    
  GKL -  Counter, Cell, Automated (Particle Counter) II
  GKX -  Instrument, Automated Platelet Counting II
  LKM -  Counter, Urine Particle II
864.5220 Automated differential cell counter.    
  MAM -  Dna-Probe, B And T Lymphocyte II
  OYE -  Flow Cytometric Reagents And Accessories. II
  PMG -  Automated Multicolor Fluorescent Imaging Cytometric Analysis System II
  POV -  Semen Analysis Device II
  LIZ -  Assay, T Lymphocyte Surface Marker II
  LJD -  Assay, B Lymphocyte Marker II
  NID -  Assay, Proliferation, In Vitro, T Lymphocyte II
  PDX -  Flow Cytometry Calibrator II
864.5260 Automated cell-locating device.    
  JOY -  Device, Automated Cell-Locating II
864.5300 Red cell indices device.    
  JBW -  Red-Cell Indices, Measured II
  JPJ -  Red-Cell Indices, Calculated II
  KQH -  Red-Cell Indices II
864.5400 Coagulation instrument.    
  GKN -  Timer, Clot, Automated II
  GKP -  Instrument, Coagulation, Automated II
  KQG -  Instrument, Coagulation II
864.5425 Multipurpose system for in vitro coagulation studies.    
  JPA -  System, Multipurpose For In Vitro Coagulation Studies II
  LGP -  Assay, Alpha-2-Antiplasmin II
  LLG -  Kit, Igg, Platelet Associated II
864.5680 Automated heparin analyzer.    
  JOX -  Analyzer, Heparin, Automated II
864.5700 Automated platelet aggregation system.    
  GHR -  Reagent, Platelet Aggregation II
  JOZ -  System, Automated Platelet Aggregation II
  OBW -  11-Dehydro Thromboxane B2 Kit, Urinary II
864.5950 Blood volume measuring device.    
  JWO -  Device, Blood Volume Measuring II
864.6550 Occult blood test.    
  GGG -  Guaiac Reagent II
  JIO -  Blood, Occult, Colorimetric, In Urine II
  JIP -  Blood, Occult, Enzymatic Method, In Urine II
  KHE -  Reagent, Occult Blood II
  OOX -  Automated Occult Blood Analyzer II
  NGK -  Test, Occult Blood, Over The Counter II
864.6675 Platelet aggregometer.    
  GKW -  Aggregometer, Platelet, Thrombokinetogram II
  JBX -  Aggregrometer, Platelet II
  JBY -  Aggregometer, Platelet, Photo-Optical Scanning II
864.7010 Flow cytometric test system for hematopoietic neoplasms.    
  PWD -  Flow Cytometric Test System For Hematopoietic Neoplasms II
864.7060 Antithrombin III assay.    
  DDQ -  Antigen, Antiserum, Control, Antithrombin Iii II
  JBQ -  Antithrombin Iii Quantitation II
  JPE -  Antithrombin Iii, Two Stage Clotting Time Assay II
864.7100 Red blood cell enzyme assay.    
  JBE -  Cell Enzymes (Erythrocytic And Leukocytic) II
  LKZ -  Red-Cell Count By Photometry II
864.7140 Activated whole blood clotting time tests.    
  JBP -  Activated Whole Blood Clotting Time II
864.7250 Erythropoietin assay.    
  GGT -  Assay, Erythropoietin II
864.7280 Factor V Leiden DNA mutation detection systems.    
  OMM -  Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr II
864.7290 Factor deficiency test.    
  GGP -  Test, Qualitative And Quantitative Factor Deficiency II
  GJT -  Plasma, Coagulation Factor Deficient II
864.7320 Fibrinogen/fibrin degradation products assay.    
  DAP -  Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control II
  GHH -  Fibrin Split Products II
  MIF -  Prothrombin Fragment 1.2 II
864.7340 Fibrinogen determination system.    
  DAR -  Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control II
  DAT -  Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control II
  DAX -  Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control II
  DAZ -  Fibrinogen And Split Products, Antigen, Antiserum, Control II
  GFK -  Fibrinogen Determination Standards And Controls II
  GIS -  Test, Fibrinogen II
  KQJ -  System, Fibrinogen Determination II
864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.    
  JBF -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening II
  JBG -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot II
  JBH -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod II
  JBI -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition II
  JBJ -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction II
  JBK -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic II
  JBL -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative II
  JBM -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis II
  JLM -  Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase II
  JMB -  Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase II
  JMC -  Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase II
  KQE -  Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase II
864.7400 Hemoglobin A2 assay.    
  JPD -  Hemoglobin A2 Quantitation II
864.7415 Abnormal hemoglobin assay.    
  GIQ -  Hemoglobin S II
  GKA -  Abnormal Hemoglobin Quantitation II
  JPB -  Hemoglobin M II
  MLL -  Hemoglobin C (Abnormal Hemoglobin Variant) II
864.7425 Carboxyhemoglobin assay.    
  GHS -  Assay, Carboxyhemoglobin II
864.7440 Electrophoretic hemoglobin analysis system.    
  JBD -  System, Analysis, Electrophoretic Hemoglobin II
864.7455 Fetal hemoglobin assay.    
  GHA -  Hemoglobin, Alkali Resistant II
  JPC -  Hemoglobin F Quantitation II
  KQI -  Assay, Fetal Hemoglobin II
864.7490 Sulfhemoglobin assay.    
  GJC -  Assay, Sulfhemoglobin II
864.7500 Whole blood hemoglobin assays.    
  GGZ -  Oxyhemoglobin II
  GIG -  Hemoglobinometer II
  GJZ -  Cyanomethemoglobin Reagent And Standard Solution II
  GKK -  Cyanomethemoglobin II
  GLY -  Oximeter To Measure Hemoglobin II
  KHG -  Whole Blood Hemoglobin Determination II
  LGL -  Assay, Bart'S, Hemoglobin II
864.7525 Heparin assay.    
  GFT -  Protamine Sulphate II
  JBR -  Test, Heparin Neutralization II
  KFF -  Assay, Heparin II
864.7695 Platelet factor 4 radioimmunoassay.    
  LCO -  Platelet Factor 4 Radioimmunoassay II
864.7750 Prothrombin time test.    
  ODV -  Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System II
864.7825 Sickle cell test.    
  GHM -  Test, Sickle Cell II
  JBB -  Solubility, Hemoglobin, Abnormal II
864.7875 Thrombin time test.    
  GJA -  Test, Thrombin Time II
  GJB -  Thrombin II
864.7925 Partial thromboplastin time tests.    
  GFO -  Activated Partial Thromboplastin II
  GGO -  Reagent, Thromboplastin And Control II
  GGW -  Test, Time, Partial Thromboplastin II
  GIT -  Reagent & Control, Partial Thromboplastin Time II
864.8100 Bothrops atrox reagent.    
  JCO -  Bothrops Atrox Reagent II
864.8950 Russell viper venom reagent.    
  GIR -  Reagent, Russel Viper Venom I
864.9650 Quality control kit for blood banking reagents.    
  PFK -  Quality Control For Molecular Immunohematology Tests II

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