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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 023 FR Publication Date: 05/05/2010 

Part B: Supplementary Information

Recognition Number 7-205: CLSI H47-A2, one-stage prothrombin time (pt) test and activated partial thromboplastin time (aptt) test; approved guideline. (InVitro Diagnostics)

Date of Standard: 2008. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
CDRH Office and Division associated with recognized standards:
Devices Affected:
Manual, semi-automated, and automated devices which perform Prothrombim Time/International Normalized Ratio (PT/INR) and Activated Partial Thromboplastin Time (APTT)
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Device Name Device
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7925 Activated Partial Thromboplastin Class 2 GFO
Relevant Guidance:
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact: