Cleared Traditional

EQ-PRC LC WARFARIN GENOTYPING KIT

K073071 · Trimgen Corporation · Toxicology

Feb 2009

Decision

464d

Days

Class 2

Risk

About This 510(k) Submission

K073071 is an FDA 510(k) clearance for the EQ-PRC LC WARFARIN GENOTYPING KIT, a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II — Special Controls, product code ODW), submitted by Trimgen Corporation (Sparks, US). The FDA issued a Cleared decision on February 6, 2009, 464 days after receiving the submission on October 31, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K073071 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2007
Decision Date	February 06, 2009
Days to Decision	464 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.