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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 036 Date of Entry 07/09/2014 
FR Recognition Number 7-221
Standard
CLSI  GP39-A6 (Formerly H01-A6)
Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
Scope/Abstract
This document is a performance standard for manufacturers of venous and capillary blood collection tubes and additives for serum, plasma, and whole blood testing. H01 addresses requirements for the materials, construction, and labeling of venous and capillary blood collection tubes and tube assemblies.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1675 Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

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
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6138
  yung.chan@fda.hhs.gov
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.
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