# K101683: Infiniti CYP2C19 Assay

- Pathway: 510(k) (Abbreviated)
- Applicant: Autogenomics, Incorporated
- Decided: Oct 25, 2010 after 132 days
- Product code: NTI (Drug Metabolizing Enzyme Genotyping Systems)
- 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: 3 generations back to DEN040011 (2004). 4 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin, Autogenomics, Incorporated (2008) Summary page 1.
- K043576: Roche Amplichip CYP450 Test, Roche Molecular Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- 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 CYP2Cl 9 Assay is an in vitro diagnostic test for the identification of a patient's CYP45O 2C09 genotype in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI CYP2CI 9 Assay is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI CYP2Cl 9 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP45O 2C1 9 gene product, specifically *2, *3, *17. The INFINITI CYP2Cl9 Assay is not indicated to be used to predict drug response or non-response.

Source page: https://510kreport.com/device/K101683
Methodology: https://510kreport.com/methodology