# K093420: Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254)

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Aug 26, 2010 after 296 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: 1 generation back to DEN040011 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040011: Amplichip CYP450 Test, Model 04381866190, Roche Molecular Systems, Inc. (2004). Our reading of the summary gave K042259, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040011, Amplichip CYP450 Test, Model 04381866190 (Roche Molecular Systems, Inc.), granted Dec 23, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Recalls of this device
- May 24, 2011 · Not classified · Z-3112-2011: Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.

## Indications for use
The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

Source page: https://510kreport.com/device/K093420
Methodology: https://510kreport.com/methodology