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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 7-301
CLSI  GP42 7th Edition
Collection of Capillary Blood Specimens
This standard describes the process and related procedures for collecting diagnostic capillary blood specimens,
including capillary blood gases. It is intended for health care professionals responsible for obtaining specimens from patients, as well as for manufacturers of capillary puncture and incision devices and microcollection containers. GP42 also establishes requirements for single-use disposable devices for collecting, processing, and transferring capillary blood specimens, including those for point-of-care testing. This standard does not cover capillary puncture procedures for self-testing, nor does it cover procedures for point-of-care testing.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1225 Electrode, Ion Based, Enzymatic, Creatinine Class 2 CGL
§862.1225 Alkaline Picrate, Colorimetry, Creatinine Class 2 CGX
§862.1225 Enzymatic Method, Creatinine Class 2 JFY
§862.1225 Test, Cystatin C Class 2 NDY
§862.1225 Test, Creatinine, Over The Counter Class 2 NFZ
§862.1345 Hexokinase, Glucose Class 2 CFR
§862.1345 Copper Reduction, Glucose Class 2 CFW
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
§862.1345 Ferricyanide, Glucose Class 2 CGD
§862.1345 Orthotoluidine, Glucose Class 2 CGE
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
§862.1345 Drink, Glucose Tolerance Class 2 MRV
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Yung Chan
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.