# K170492: xTAG CYP2D6 Kit v3

- Pathway: 510(k) (Special)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Aug 11, 2017 after 175 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.

Source page: https://510kreport.com/device/K170492
Methodology: https://510kreport.com/methodology