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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: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five 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 indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Clinical Chemistry

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
862.1020 Acid phosphatase (total or prostatic) test system. II  
  CJN -  Acid Phosphatase, Nitrophenylphosphate   Pilot  
  CJR -  Acid Phosphatase, Thymol Blue Monophosphate   Pilot  
  CJX -  Acid Phosphatase, Disodium Phenylphosphate   Pilot  
  CKB -  Acid Phosphatase, Naphthyl Phosphate   Pilot  
  CKE -  Acid Phosphatase, Thymolphthale Inmonophosphate   Pilot  
  CKH -  Acid Phosphatase, Beta Glycerophosphate   Pilot  
  JFH -  Acid Phosphatase (Prostatic), Tartrate Inhibited   Pilot  
862.1025 Adrenocorticotropic hormone (ACTH) test system. II  
  CKG -  Radioimmunoassay, Acth   Pilot  
862.1035 Albumin test system. II  
  CIX -  Bromcresol Green Dye-Binding, Albumin   Pilot  
  CJF -  Tetrabromophenolphthalein, Albumin   Pilot  
  CJG -  Tetrabromo-M-Cresolsulfonphthalein, Albumin   Pilot  
  CJQ -  Radial Immunodiffusion, Albumin   Pilot  
  CJW -  Bromcresol Purple Dye-Binding, Albumin   Pilot  
  CJZ -  Acid, Hydroxyazobenzene-Benzoic, Albumin   Pilot  
862.1045 Aldosterone test system. II  
  CJB -  Chromatographic Separation/Radioimmunoassay, Aldosterone   Pilot  
  CJM -  Radioimmunoassay, Aldosterone   Pilot  
862.1050 Alkaline phosphatase or isoenzymes test system. II  
  CIN -  Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   Pilot  
  CIO -  Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CJE -  Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CJH -  Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CJI -  Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CJK -  Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CJL -  Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CJO -  Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
  CKF -  Phenylphosphate, Alkaline Phosphatase Or Isoenzymes   Pilot  
862.1065 Ammonia test system. I  
 General Guidance
  JID -  Photometric Method, Ammonia      
  JIE -  Method, Ion-Exchange, Ammonia      
  JIF -  Enzymatic Method, Ammonia      
  JIG -  Electrode, Ion-Specific Method, Ammonia      
862.1070 Amylase test system. II  
  CIJ -  Saccharogenic, Amylase   Pilot  
  CIK -  Radial Diffusion, Amylase   Pilot  
  CIW -  Starch-Dye Bound Polymer, Amylase   Pilot  
  CJD -  Nitrosalicylate Reduction, Amylase   Pilot  
  JFJ -  Catalytic Methods, Amylase   Pilot  
  KHM -  Nephelometric, Amylase   Pilot  
862.1085 Angiotensin I and renin test system. II  
  CIB -  Radioimmunoassay, Angiotensin I And Renin   Pilot  
862.1090 Angiotensin converting enzyme (A.C.E.) test system. II  
  KQN -  Radioassay, Angiotensin Converting Enzyme   Pilot  
862.1100 Aspartate amino transferase (AST/SGOT) test system. II  
  CIF -  Vanillin Pyruvate, Ast/Sgot   Pilot  
  CIQ -  Diazo, Ast/Sgot   Pilot  
  CIS -  Hydrazone Colorimetry, Ast/Sgot   Pilot  
  CIT -  Nadh Oxidation/Nad Reduction, Ast/Sgot   Pilot  
862.1110 Bilirubin (total or direct) test system. II  
  CIG -  Diazo Colorimetry, Bilirubin   Pilot  
  JFM -  Enzymatic Method, Bilirubin   Pilot  
862.1113 Bilirubin (total and unbound) in the neonate test system. I  
 General Guidance
  MQM -  Bilirubin (Total And Unbound) In The Neonate Test System      
862.1118 Biotinidase test system. II  
  NAK -  System,Test,Biotinidase   Pilot  
862.1120 Blood gases (PCO2, PO2) and blood pH test system. II  
  CHL -  Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   Pilot  
862.1140 Calcitonin test system. II  
  JKR -  Radioimmunoassay, Calcitonin   Pilot  
862.1145 Calcium test system. II  
  CHC -  Titrimetric Permanganate And Bromophenol Blue, Calcium   Pilot  
  CHW -  Titrimetric With Edta And Indicator, Calcium   Pilot  
  CHZ -  Di (O-Hydroxyphenylimine) Ethane, Calcium   Pilot  
  CIA -  Methylthymol Blue, Calcium   Pilot  
  CIC -  Cresolphthalein Complexone, Calcium   Pilot  
  CID -  Alizarin Sulfonate, Calcium   Pilot  
  CJY -  Azo Dye, Calcium   Pilot  
  JFN -  Atomic Absorption, Calcium   Pilot  
  JFO -  Fluorometric, Calcium   Pilot  
  JFP -  Electrode, Ion Specific, Calcium   Pilot  
862.1150 Calibrator. II  
PDF Guidance file for Calibrator. (21CFR862.1150)  
  JIS -  Calibrator, Primary      
  JIT -  Calibrator, Secondary      
  JIW -  Calibrator, Surrogate      
  JIX -  Calibrator, Multi-Analyte Mixture      
862.1155 Human chorionic gonadotropin (HCG) test system. II  
PDF Guidance file for Human chorionic gonadotropin (HCG) test system. (21CFR862.1155)  
PDF Guidance file for Human chorionic gonadotropin (HCG) test system. (21CFR862.1155)  
  DHA -  System, Test, Human Chorionic Gonadotropin      
  JHI -  Visual, Pregnancy Hcg, Prescription Use      
  JHJ -  Agglutination Method, Human Chorionic Gonadotropin      
  LFS -  Radioreceptor Assay, Human Chorionic Gonadotropin      
  NAL -  Test,Immunoassay,Biosensor,Hcg   Pilot  
862.1160 Bicarbonate/carbon dioxide test system. II  
PDF Guidance file for Bicarbonate/carbon dioxide test system. (21CFR862.1160)  
  CHR -  Titrimetric Phenol Red, Carbon-Dioxide      
  CHS -  Coulometric Method, Carbon-Dioxide      
  CIE -  Volumetric/Manometric, Carbon-Dioxide      
  CIL -  Cresol Red Colorimetry, Carbon-Dioxide      
  JFL -  Ph Rate Measurement, Carbon-Dioxide      
  KHS -  Enzymatic, Carbon-Dioxide      
  KMS -  Phenolphthalein Colorimetry, Carbon-Dioxide      
862.1170 Chloride test system. II  
PDF Guidance file for Chloride test system. (21CFR862.1170)  
  CGZ -  Electrode, Ion-Specific, Chloride      
  CHG -  Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride      
  CHJ -  Mercuric Thiocyanate, Colorimetry, Chloride      
  CHK -  Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride      
  JFS -  Coulometric, Chloride      
862.1177 Cholylglycine test system. II  
  KWW -  Radioimmunoassay, Cholyglycine, Bile Acids   Pilot  
862.1187 Conjugated sulfolithocholic acid (SLCG) test system. II  
  KWX -  Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids   Pilot  
862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. II  
  CGR -  Radioimmunoassay, Cortisol   Pilot  
  JFT -  Fluorometric, Cortisol   Pilot  
  NHG -  Enzyme Immunoassay, Cortisol, Salivary   Pilot  
862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system. II  
  CGS -  Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   Pilot  
  JHS -  Differential Rate Kinetic Method, Cpk Or Isoenzymes   Pilot  
  JHT -  Chromatographic Separation, Cpk Isoenzymes   Pilot  
  JHW -  U.V. Method, Cpk Isoenzymes   Pilot  
  JHX -  Fluorometric Method, Cpk Or Isoenzymes   Pilot  
  JHY -  Colorimetric Method, Cpk Or Isoenzymes   Pilot  
  MMI -  Immunoassay Method, Troponin Subunit   Pilot  
  MYT -  Biosensor, Immunoassay, Cpk Or Isoenzymes   Pilot  
862.1225 Creatinine test system. II  
PDF Guidance file for Creatinine test system. (21CFR862.1225)  
  CGL -  Electrode, Ion Based, Enzymatic, Creatinine      
  CGX -  Alkaline Picrate, Colorimetry, Creatinine      
  JFY -  Enzymatic Method, Creatinine      
862.1230 Cyclic AMP test system. II  
  CGT -  Radioimmunoassay, Cyclic Gmp   Pilot  
  CHO -  Radioimmunoassay, Cyclic Amp   Pilot  
862.1295 Folic acid test system. II  
  CGN -  Acid, Folic, Radioimmunoassay   Pilot  
862.1310 Galactose test system. I  
 General Guidance
  JIA -  Enzymatic Methods, Galactose      
  JIB -  U.V. Method, Galactose      
  JIC -  Colorimetric Method, Galactose      
862.1315 Galactose-1-phosphate uridyl transferase test system. II  
  JLJ -  Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate   Pilot  
  KQP -  Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase   Pilot  
862.1340 Urinary glucose (nonquantitative) test system. II  
PDF Guidance file for Urinary glucose (nonquantitative) test system. (21CFR862.1340)  
  JIL -  Method, Enzymatic, Glucose (Urinary, Non-Quantitative)      
  JIM -  Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)   Pilot  
862.1345 Glucose test system. II  
  HTML Guidance file for Glucose test system. (21CFR862.1345)
PDF Guidance file for Glucose test system. (21CFR862.1345)  
PDF Guidance file for Glucose test system. (21CFR862.1345)  
  CFR -  Hexokinase, Glucose      
  CFW -  Copper Reduction, Glucose      
  CGA -  Glucose Oxidase, Glucose      
  CGD -  Ferricyanide, Glucose      
  CGE -  Orthotoluidine, Glucose      
  LFR -  Glucose Dehydrogenase, Glucose      
  MRV -  Drink, Glucose Tolerance      
862.1377 Urinary homocystine (nonquantitative) test system. II  
  LPS -  Urinary Homocystine (Nonquantitative) Test System   Pilot  
862.1410 Iron (non-heme) test system. I  
 General Guidance
  CFM -  Bathophenanthroline, Colorimetry, Iron (Non-Heme)      
  JIY -  Photometric Method, Iron (Non-Heme)      
  JIZ -  Atomic Absorption, Iron (Non-Heme)      
  JJA -  Radio-Labeled Iron Method, Iron (Non-Heme)      
862.1415 Iron-binding capacity test system. I  
 General Guidance
  JMO -  Ferrozine (Colorimetric) Iron Binding Capacity      
  JQD -  Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity      
  JQE -  Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity      
  JQF -  Bathophenanthroline, Iron Binding Capacity      
  JQG -  Radiometric, Fe59, Iron Binding Capacity      
862.1445 Lactate dehydrogenase isoenzymes test system. II  
  CEX -  Chromatographic Separation, Lactate Dehydrogenase Isoenzymes   Pilot  
  CFE -  Electrophoretic, Lactate Dehydrogenase Isoenzymes   Pilot  
  JGF -  Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes   Pilot  
862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system. II  
  JHF -  Colorimetric Method, Lecithin/Sphingomyelin Ratio   Pilot  
  JHG -  Chromatographic Separation, Lecithin/Sphingomyelin Ratio   Pilot  
  JHH -  Electrophoretic Method, Lecithin/Sphingomyelin Ratio   Pilot  
862.1495 Magnesium test system. I  
 General Guidance
  CFA -  Electrode, Ion Specific, Magnesium      
  CFO -  Titrimetric, Magnesium      
  JGI -  Atomic Absorption, Magnesium      
  JGJ -  Photometric Method, Magnesium      
862.1509 Methylmalonic acid (nonquantitative) test system. II  
  LPT -  System, Test, Urinary Methylmalonic Acid   Pilot  
862.1545 Parathyroid hormone test system. II  
  CEW -  Radioimmunoassay, Parathyroid Hormone   Pilot  
862.1555 Phenylalanine test system. II  
  JNB -  Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine   Pilot  
  JNC -  Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine   Pilot  
862.1580 Phosphorus (inorganic) test system. I  
 General Guidance
  CEO -  Phosphomolybdate (Colorimetric), Inorganic Phosphorus      
862.1585 Human placental lactogen test system. II  
  JMF -  Radioimmunoassay, Human Placental Lactogen   Pilot  
862.1600 Potassium test system. II  
PDF Guidance file for Potassium test system. (21CFR862.1600)  
  CEJ -  Tetraphenyl Borate, Colorimetry, Potassium      
  CEM -  Electrode, Ion Specific, Potassium      
  JGM -  Flame Photometry, Potassium      
  MZV -  Test,System,Potassium,Enzymatic Method      
862.1660 Quality control material (assayed and unassayed). I  
 General Guidance
  JJR -  Electrolyte Controls (Assayed And Unassayed)      
  JJS -  Controls For Blood-Gases, (Assayed And Unassayed)      
  JJT -  Enzyme Controls (Assayed And Unassayed)      
  JJW -  Urinalysis Controls (Assayed And Unassayed)      
  JJX -  Single (Specified) Analyte Controls (Assayed And Unassayed)      
  JJY -  Multi-Analyte Controls, All Kinds (Assayed)      
  LCH -  Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical      
  MJX -  Kit, Serological, Positive Control      
  MJY -  Kit, Serological, Negative Control      
  MJZ -  Kit, Direct Antigen, Positive Control      
  MKA -  Kit, Direct Antigen, Negative Control      
862.1665 Sodium test system. II  
PDF Guidance file for Sodium test system. (21CFR862.1665)  
  CEI -  Uranyl Acetate/Zinc Acetate, Sodium      
  JGS -  Electrode, Ion Specific, Sodium      
  JGT -  Flame Photometry, Sodium      
  MZU -  System,Test,Sodium,Enzymatic Method      
862.1675 Blood specimen collection device. II  
  GIM -  Tubes, Vacuum Sample, With Anticoagulant   Pilot  
  GJE -  Tray, Blood Collection   Pilot  
  JKA -  Tubes, Vials, Systems, Serum Separators, Blood Collection   Pilot  
862.1680 Testosterone test system. I  
 General Guidance
  CDZ -  Radioimmunoassay, Testosterones And Dihydrotestosterone      
862.1685 Thyroxine-binding globulin test system. II  
  CEE -  Radioimmunoassay, Thyroxine-Binding Globulin   Pilot  
862.1690 Thyroid stimulating hormone test system. II  
  JLW -  Radioimmunoassay, Thyroid-Stimulating Hormone   Pilot  
862.1695 Free thyroxine test system. II  
  CEC -  Radioimmunoassay, Free Thyroxine   Pilot  
862.1700 Total thyroxine test system. II  
  CDX -  Radioimmunoassay, Total Thyroxine   Pilot  
  KLI -  Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   Pilot  
862.1730 Free tyrosine test system. I  
 General Guidance
  CDR -  1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine      
862.1770 Urea nitrogen test system. II  
PDF Guidance file for Urea nitrogen test system. (21CFR862.1770)  
  CDL -  Berthelot Indophenol, Urea Nitrogen      
  CDN -  Urease, Photometric, Urea Nitrogen      
  CDQ -  Urease And Glutamic Dehydrogenase, Urea Nitrogen      
  CDS -  Electrode, Ion Specific, Urea Nitrogen      
  CDW -  Diacetyl-Monoxime, Urea Nitrogen      
  JGZ -  O-Phthalaldehyde, Urea Nitrogen      
  LFP -  Conductivity Rate, Urea Nitrogen      
862.1775 Uric acid test system. I  
 General Guidance
  CDH -  Acid, Uric, Phosphotungstate Reduction      
  CDO -  Acid, Uric, Uricase (U.V.)      
  JHA -  Acid, Uric, Uricase (Gasometric)      
  JHC -  Acid, Uric, Uricase (Oxygen Rate)      
  KNK -  Acid, Uric, Uricase (Colorimetric)      
  LFQ -  Acid, Uric, Acid Reduction Of Ferric Ion      
862.1810 Vitamin B12 test system. II  
  CDD -  Radioassay, Vitamin B12   Pilot  
  LIG -  Radioassay, Intrinsic Factor Blocking Antibody   Pilot  
862.1825 Vitamin D test system. II  
  MRG -  System, Test, Vitamin D   Pilot  
862.2250 Gas liquid chromatography system for clinical use. I  
  JXQ -  Monitor, U.V., Glc   Pilot  

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