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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 050 Date of Entry 09/17/2018 
FR Recognition Number 7-277
CLSI  GP41 7th Edition
Collection of Diagnostic Venous Blood Specimens
This standard establishes criteria for suitable venous blood specimen collection for medical laboratory testing. These procedures are intended as an appropriate model for adoption by all health care providers responsible for blood specimen collection in outpatient and inpatient settings.
Extent of Recognition
Complete standard
Rationale for Recognition
The standard provides processes and procedures that are appropriate for venous blood specimen collection for the clinical laboratory testing.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1675 Blood specimen collection device. Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Blood specimen collection device. Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
§864.5220 Counter, Differential Cell Class 2 GKZ
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7925 Activated Partial Thromboplastin Class 2 GFO
Relevant FDA Guidance and/or Supportive Publications*
CLSI GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition.

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
 Yvonne Doswell
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.