Cleared Traditional

VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST

K070804 · Nanosphere, Inc. · Toxicology

Sep 2007

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K070804 is an FDA 510(k) clearance for the VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST, a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II — Special Controls, product code ODW), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on September 17, 2007, 178 days after receiving the submission on March 23, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K070804 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2007
Decision Date	September 17, 2007
Days to Decision	178 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.