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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 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 Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
§864.7925 Activated Partial Thromboplastin Class 2 GFO
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.5220 Counter, Differential Cell Class 2 GKZ
Relevant FDA Guidance and/or Supportive Publications*
CLSI GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition.
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.