# K110786: Esensor Warfarin Sensitivity Saliva Test

- Pathway: 510(k) (Traditional)
- Applicant: GenMark Diagnostics, Inc.
- Decided: Dec 2, 2011 after 255 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K073720 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073720: Esensor Warfarin Sensitivity and XT-8 Instrument, Osmetech Molecular Diagnostics (2008) Summary page 2.

## Most influential descendants
- K152612: eSensor Warfarin Sensitivity Saliva Test (2016), 0 descendants of its own

## Indications for use
The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA extracted from human saliva samples collected using the the Oragene® Dx Device, as an aid in the identification of patients at risk for increased warfarin sensitivity.

Source page: https://510kreport.com/device/K110786
Methodology: https://510kreport.com/methodology