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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 020 Date of Entry 09/09/2008 
FR Recognition Number 7-159
CLSI  H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
This document contains procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and provides general recommendations for performing the tests.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.5400 Fibrometer Class 2 GIE
§864.5425 Control, Plasma, Abnormal Class 2 GGC
§864.5425 Plasma, Coagulation Control Class 2 GGN
§864.5425 Plasma, Control, Normal Class 2 GIZ
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§864.5680 Analyzer, Heparin, Automated Class 2 JOX
§864.7060 Antigen, Antiserum, Control, Antithrombin Iii Class 2 DDQ
§864.7060 Antithrombin Iii Quantitation Class 2 JBQ
§864.7060 Antithrombin Iii, Two Stage Clotting Time Assay Class 2 JPE
§864.7290 Test, Qualitative And Quantitative Factor Deficiency Class 2 GGP
§864.7290 Plasma, Coagulation Factor Deficient Class 2 GJT
§864.7320 Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class 2 DAP
§864.7320 Fibrin Split Products Class 2 GHH
§864.7525 Protamine Sulphate Class 2 GFT
§864.7525 Test, Heparin Neutralization Class 2 JBR
§864.7525 Assay, Heparin Class 2 KFF
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7875 Test, Thrombin Time Class 2 GJA
§864.7875 Thrombin Class 2 GJB
§864.7925 Activated Partial Thromboplastin Class 2 GFO
§864.7925 Reagent, Thromboplastin And Control Class 2 GGO
§864.7925 Test, Time, Partial Thromboplastin Class 2 GGW
§864.7925 Reagent & Control, Partial Thromboplastin Time Class 2 GIT
§864.8950 Reagent, Russel Viper Venom Class 1 GIR
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition.

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
 Iwona Fijalkowska
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.