CLSI H21-A5

Standard Organization:

CLSI H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays

Recognition Date2008-09-09
Recognition List020
Recognition Number7-159
Extent Complete standard
Standards Orgs CLSI Clinical Laboratory Standards Institute https://clsi.org/
STG InVitro Diagnostics
FDA Tech  Iwona Fijalkowska   FDA/OMPT/CDRH/OIR/DIHD/HEMB/   301-796-6205   iwona.fijalkowska@fda.hhs.gov

Rationale:

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Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§864.8950 Reagent, Russel Viper Venom Class 1 GIR
§864.7925 Activated Partial Thromboplastin Class 2 GFO
§864.7925 Reagent & Control, Partial Thromboplastin Time Class 2 GIT
§864.7925 Reagent, Thromboplastin And Control Class 2 GGO
§864.7925 Test, Time, Partial Thromboplastin Class 2 GGW
§864.7875 Test, Thrombin Time Class 2 GJA
§864.7875 Thrombin Class 2 GJB
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7525 Assay, Heparin Class 2 KFF
§864.7525 Protamine Sulphate Class 2 GFT
§864.7525 Test, Heparin Neutralization Class 2 JBR
§864.7320 Fibrin Split Products Class 2 GHH
§864.7320 Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class 2 DAP
§864.7290 Plasma, Coagulation Factor Deficient Class 2 GJT
§864.7290 Test, Qualitative And Quantitative Factor Deficiency Class 2 GGP
§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
§864.5680 Analyzer, Heparin, Automated Class 2 JOX
§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
§864.5400 Fibrometer Class 2 GIE

FDA Guidance:

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.




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