| CLSI H47-A2 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition. |
| Recognition Date | 2010-05-05 |
| Recognition List | 023 |
| Recognition Number | 7-205 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Khanh Nghiem FDA/OMPT/CDRH/OIR/DIHD/HEMB/ 240-402-5770 KHANH.NGHIEM@FDA.HHS.GOV |
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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).
| Regulation Number | Device Name | Device Class | Product Code |
| §864.7925 | Activated Partial Thromboplastin | Class 2 | GFO |
| §864.7750 | Test, Time, Prothrombin | Class 2 | GJS |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994. |