# K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin

- Pathway: 510(k) (Abbreviated)
- Applicant: Autogenomics, Incorporated
- Decided: Jan 23, 2008 after 90 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: 2 generations back to DEN040011 (2004). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043576: Roche Amplichip CYP450 Test, Roche Molecular Systems, Inc. (2005) Summary page 2.
- K060564: Infiniti System, AutoGenomics, Inc. (2007) Summary page 2.

## Most influential descendants
- K101683: Infiniti CYP2C19 Assay (2010), 3 descendants of its own
- K123891: Spartan RX CYP2C19 Test System (2013), 1 descendant of its own
- K220026: Genomadix Cube CYP2C19 System (2023), 0 descendants of its own
- K120466: Verigene CYP2C19 Nucleic Acid Tes (2C19) (2012), 0 descendants of its own

## Indications for use
The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic test for the detection and genotyping of the *2 and *3 CYP4502C9 genetic variants and the VKORC1 3673 (-1639) intronic variant in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is indicated for use to identify individuals at risk for sensitivity to warfarin.

Source page: https://510kreport.com/device/K073014
Methodology: https://510kreport.com/methodology