# K073071: EQ-PRC LC Warfarin Genotyping Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trimgen Corporation
- Decided: Feb 6, 2009 after 464 days
- Product code: ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System)
- Device class: 2
- Regulation: 21 CFR 862.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN040011 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070804: Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test, Nanosphere, Inc. (2007) Summary page 1.

## Indications for use
The eQ-PCRTM LC Warfarin Genotyping kit is an in vitro diagnostic test for the detection and genotyping of two single nucleotide polymorphisms (SNP) in the cytochrome P450 enzyme gene CYP2C9 known as CYP2C9*2 (C430T) and CYP2C9*3 (Al 075C), and a SNP in the vitamin K epoxide reductase complex 1 gene VKORC1, known as VKORC1 (-1 639G>A) obtained from EDTA - anticoagulated whole blood samples. The eQ-PCR LC Warfarin Genotyping kit is used as an aid in the identification of patients at risk for increased warfarin sensitivity. It is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.

Source page: https://510kreport.com/device/K073071
Methodology: https://510kreport.com/methodology