Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-162: CLSI H49-A, Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline. (InVitro Diagnostics)

Date of Standard: 2004. 

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 IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)

(2) OFFICE OF COMPLIANCE (OC)

Devices Affected:

In Vitro diagnostic POC/POL devices for the measurement of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Activated Whole Blood Clotting Time tests (ACT), Heparin Concentration and Coagulation Instruments

Processes Affected:

510(k), PDP, IDE, HDEM PMA

Type of Standard:

 Vertical, National

Extent of Recognition:

Complete Standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§862.1150	Calibrator, Primary	Class 2	JIS
Regulation Number	Device Name	Device Class	Product Code
§864.5400	Fibrometer	Class 2	GIE
§864.5400	Instrument, Coagulation	Class 2	KQG
§864.5400	Instrument, Coagulation, Automated	Class 2	GKP
§864.5400	Timer, Clot, Automated	Class 2	GKN
§864.5400	Timer, Coagulation	Class 2	JBT
Regulation Number	Device Name	Device Class	Product Code
§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
§864.7140	Activated Whole Blood Clotting Time	Class 2	JBP
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
§864.7925	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

Relevant Guidance:

Point to consider for Collection of Data in Support of In Vitro Device Submission for 510(k) clearance

510(k) Submission for Coagulation Instruments - Guidance for Industry and FDA Staff

FDA Technical Contact:

  Lea Carrington

  FDA/CDRH/OIVD

  10903 New Hampshire Avenue Building 66, Room 4224

  Silver Spring MD 20993

  301/796-6164

  Email: lea.carrington@fda.hhs.gov