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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 023 Date of Entry 05/05/2010 
FR Recognition Number 7-205
Standard
CLSI  H47-A2
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
Scope/Abstract
This standard describes the principles and procedures necessary for the routine performance of the PT and APTT by conventional techniques using citrated plasma. Each of the two tests measures the time for a fibrin clot to develop in test plasma after activation. The chemical reactions are complex and, characteristically, results are affected by preexamination (preanalytical) and examination (analytical) variables. The PT and APTT are important screening tests used in laboratory evaluation of patients suspected to have disorders of blood coagulation, including the presence of circulating coagulation inhibitors. The PT measures the extrinsic or tissue factor pathway of the coagulation system and is used to monitor oral anticoagulant therapy. The APTT measures the intrinsic coagulation pathway and is used in monitoring heparin therapy. The objective of this guideline is to improve test reproducibility through standardization of technique and ensure clinical relevance by setting test performance goals. The document also highlights the international effort for standardization of the PT through the use of the international normalized ratio (INR).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.7750 Test, Time, Prothrombin Class 2 GJS
§864.7925 Activated Partial Thromboplastin Class 2 GFO
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

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
 Khanh Nghiem
  FDA/OMPT/CDRH/OIR/DIHD/HEMB/
  240-402-5770
  KHANH.NGHIEM@FDA.HHS.GOV
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.
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