Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7750](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7750) → ODV — Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

# ODV · Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

_Hematology · 21 CFR 864.7750 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/ODV

## Overview

- **Product Code:** ODV
- **Device Name:** Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
- **Regulation:** [21 CFR 864.7750](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7750)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/ODV/K071867.md) | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA | Paragondx, LLC | Apr 28, 2008 | SESE |

## Top Applicants

- Paragondx, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/ODV](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/ODV)

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