# K070804: Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Sep 17, 2007 after 178 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN040011 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051824: Invader UGT1A1 Molecular Assay, Third Wave Technologies, Inc. (2005) Summary page 2.

## Most influential descendants
- K073071: EQ-PRC LC Warfarin Genotyping Kit (2009), 0 descendants of its own

## Recalls of this device
- Feb 25, 2008 · Not classified · Z-1383-2008: Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).

## Indications for use
The Verigene System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing gold nanoparticle probe technology. The Verigene System consists of the Verigene Processor and the Verigene Reader, each with its own onboard proprietary software. The Verigene Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a single-point polymorphism (C to T at position 1173) of the VKORCI gene, from EDTA-anticoagulated whole blood samples, as an aid in the identification of patients at risk for increased warfarin sensitivity. The test is intended to be used on the Verigene System.

Source page: https://510kreport.com/device/K070804
Methodology: https://510kreport.com/methodology