# K152612: eSensor Warfarin Sensitivity Saliva Test

- Pathway: 510(k) (Traditional)
- Applicant: Genmark Diagnostics, Incorporated
- Decided: May 26, 2016 after 255 days
- Product code: ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System)
- 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 K073720 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110786: Esensor Warfarin Sensitivity Saliva Test, GenMark Diagnostics, Inc. (2011) Summary page 5.

## 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 Oragene®•Dx and ORAcollect®•Dx devices, as an aid in the identification of patients at risk for increased warfarin sensitivity. The eSensor® XT-8 instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.

Source page: https://510kreport.com/device/K152612
Methodology: https://510kreport.com/methodology