# K120466: Verigene CYP2C19 Nucleic Acid Tes (2C19)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Nov 6, 2012 after 265 days
- Product code: NTI (Drug Metabolizing Enzyme Genotyping Systems)
- 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: 4 generations back to DEN040011 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101683: Infiniti CYP2C19 Assay, Autogenomics, Incorporated (2010) Summary page 2.

## Recalls of this device
- Mar 18, 2014 · Class III · Z-2559-2014: Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal tes

## Indications for use
The Verigene® CYP2C 19 Nucleic Acid Test (CYP2C 19 Test), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of an individual's CYP450 2C19 genotype in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test) is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, and *17. The Verigene CYP2CI9 Nucleic Acid Test (CYP2C19 Test) is not indicated to be used to predict drug response or non-response.

Source page: https://510kreport.com/device/K120466
Methodology: https://510kreport.com/methodology