Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
The VKORC1 Genotyping System (product code ODV) is a hematology in vitro diagnostic assay used to genotype vitamin K epoxide reductase complex subunit 1 (VKORC1) alleles, aiding in the identification of patients at risk for altered sensitivity to warfarin, an anticoagulant medication. VKORC1 polymorphisms are a major determinant of warfarin dose requirements. This device is FDA Class 2 under regulation 864.7750 in the Hematology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODV
- Device Class
- FDA class 2
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071867 | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA | Apr 28, 2008 | Substantially Equivalent | Paragondx, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.