# K051824: Invader UGT1A1 Molecular Assay

- Pathway: 510(k) (Traditional)
- Applicant: Third Wave Technologies, Inc.
- Decided: Aug 18, 2005 after 44 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: 2 generations back to DEN040011 (2004). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043576: Roche Amplichip CYP450 Test, Roche Molecular Systems, Inc. (2005) Summary page 3.

## Most influential descendants
- K070804: Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test (2007), 1 descendant of its own
- K073071: EQ-PRC LC Warfarin Genotyping Kit (2009), 0 descendants of its own

## Indications for use
The Invader® UGT1A1 Molecular Assay is an in vitro diagnostic test for the detection and genotyping of the *1 (TA6) and *28 (TA7) alleles of the UDP glucuronosyltransferase 1A1 (UGT1A1) gene in genomic DNA from whole peripheral blood as an aid in the identification of patients with greater risk for decreased UDP-glucuronosyltransferase activity.

Source page: https://510kreport.com/device/K051824
Methodology: https://510kreport.com/methodology