Cleared Abbreviated

INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN

K073014 · Autogenomics, Incorporated · Toxicology

Jan 2008

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K073014 is an FDA 510(k) clearance for the INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN, a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II — Special Controls, product code ODW), submitted by Autogenomics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on January 23, 2008, 90 days after receiving the submission on October 25, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K073014 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2007
Decision Date	January 23, 2008
Days to Decision	90 days
Submission Type	Abbreviated
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.