# K073720: Esensor Warfarin Sensitivity and XT-8 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Osmetech Molecular Diagnostics
- Decided: Jul 17, 2008 after 199 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
No predicates in its family tree.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nanosphere Verigene® Warfarin Metabolism Nucleic Acid Test and Verigene® System: named in the summary without a submission number

## Most influential descendants
- K110786: Esensor Warfarin Sensitivity Saliva Test (2011), 1 descendant of its own
- K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 (2009), 1 descendant of its own
- K183530: TruDiagnosis System (2019), 0 descendants of its own
- K152612: eSensor Warfarin Sensitivity Saliva Test (2016), 0 descendants of its own
- K113731: Esensor Respiratory Viral Panel (2012), 0 descendants of its own

## Indications for use
The eSensor® Warfarin Sensitivity 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 C I (VKORC 1) gene promoter polymorphism Y-J6339G>A from genomic DNA extracted from whole blood samples preserved with EDTA, 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/K073720
Methodology: https://510kreport.com/methodology