510(k) K071867
K071867 is an FDA 510(k) premarket notification submitted by Paragondx, LLC for the device "RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA". The FDA issued a decision of Substantially Equivalent on April 28, 2008. The device falls under product code ODV (Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System), a Class II device regulated under 21 CFR 864.7750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2008
- Date Received
- July 6, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
- Device Class
- Class II
- Regulation Number
- 864.7750
- Review Panel
- HE
- Submission Type
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.