Cleared Traditional

ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

K073720 · Osmetech Molecular Diagnostics · Toxicology

Jul 2008

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K073720 is an FDA 510(k) clearance for the ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT, a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II — Special Controls, product code ODW), submitted by Osmetech Molecular Diagnostics (Pasadena, US). The FDA issued a Cleared decision on July 17, 2008, 199 days after receiving the submission on December 31, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K073720 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2007
Decision Date	July 17, 2008
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	ODW — Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3360
Definition	An In Vitro Diagnostic Assay For Use In Genotyping Cytochrome P450 2c9 (cyp450 2c9) Alleles. Information About The Cyp2c9 Genotype May Be Used As An Aid To Clinicians In Determining Therapeutic Strategy For Medications That Are Metabolized By The Cyp2c9 Gene Product.