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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 7-203
CLSI GP42-A6 (Formerly H04-A6)
Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard -- Sixth Edition
This standard provides a technique for the collection of diagnostic capillary blood specimens, including recommendations for collection sites and specimen handling and identification. Specifications for disposable devices used to collect, process, and transfer diagnostic capillary blood specimens are also included.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
§862.1345 Copper Reduction, Glucose Class 2 CFW
§862.1345 Drink, Glucose Tolerance Class 2 MRV
§862.1345 Ferricyanide, Glucose Class 2 CGD
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
§862.1345 Hexokinase, Glucose Class 2 CFR
§862.1345 Orthotoluidine, Glucose Class 2 CGE
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
§862.1225 Alkaline Picrate, Colorimetry, Creatinine Class 2 CGX
§862.1225 Electrode, Ion Based, Enzymatic, Creatinine Class 2 CGL
§862.1225 Enzymatic Method, Creatinine Class 2 JFY
§862.1225 Test, Creatinine, Over The Counter Class 2 NFZ
§862.1225 Test, Cystatin C Class 2 NDY
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Yung Chan
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics