ODV · Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Hematology · 21 CFR 864.7750 · Class 2
Overview
| Product Code | ODV |
|---|---|
| Device Name | Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071867 | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA | Paragondx, LLC | Apr 28, 2008 | SESE |
Top Applicants
- Paragondx, LLC — 1 clearance
