# K131565: Xtag CYP2C19 Kit V3

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Sep 11, 2013 after 104 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The xTAGO CYP2CI9 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify' a panel of nucleotide variants found within the highly polymorphic CYP450 2Cl19 gene, located on chromosome I10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG? CYP2CI9 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C 19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response. The xTAGO CYP2CI19 Kit v3 is indicated for use with the Luminex" l00/200TM instrument or MAPGIXO with xPONENr*software systems.

Source page: https://510kreport.com/device/K131565
Methodology: https://510kreport.com/methodology