# K071867: Rapid Genotyping Assay -CYP2C9 & VKORC1, Model Catalog NO. 006+0203 Gactga

- Pathway: 510(k) (Traditional)
- Applicant: Paragondx, LLC
- Decided: Apr 28, 2008 after 297 days
- Product code: ODV (Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Rapid Genotyping Assay - CYP2C9 & VKORCI is intended to be used as an in vitro diagnostic test kit that detects the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. This test is for use with EDTA-anticoagulated whole blood samples. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity.

Source page: https://510kreport.com/device/K071867
Methodology: https://510kreport.com/methodology