Recognized Consensus Standards

Recognition List Number: 020 Publication Date: 09/09/2008 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-159: CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays. (InVitro Diagnostics)

Date of Standard: 2008. 

Address of Standards Organization:

  Clinical Laboratory Standards Institute (CLSI)

  950 West Valley Road

  Suite 2500

  Wayne, PA 19087

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
	DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)

(2)	OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
	DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)

(3)	OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
	DIVISION OF MICROBIOLOGY (DMD)

Devices Affected:

Hematology devices using blood specimens for coagulation testing.

Processes Affected:

510(k), PMA, PDP, IDE, HDE

Type of Standard:

 Vertical, National

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

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

Relevant Guidance:

NCCLS:

C28-A2 - How to Define and Determine Reference Intervals in the Clinincal Laboratory; Approved Guideline - Second Edition (2000)
H1-A5 - Tubes and Additives for Venous Blood Specimen Collection; Approved Standard - Fifth Edition (2003)
H3-A5 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard - Fifth Edition (2003)
H47-A - One Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT Test); - Approved Guideline (1996)

FDA Technical Contact:

  Valerie R. Ginyard

  FDA/CDRH/OIVD

  10903 New Hampshire Avenue Building 66, Room 4258

  Silver Spring MD 20993

  301/796-6168

  Email: valerie.ginyard@fda.hhs.gov