Cleared Abbreviated

INFINITI CYP2C19 ASSAY

K101683 · Autogenomics, Incorporated · Toxicology

Oct 2010

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K101683 is an FDA 510(k) clearance for the INFINITI CYP2C19 ASSAY, a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Autogenomics, Incorporated (Vista, US). The FDA issued a Cleared decision on October 25, 2010, 132 days after receiving the submission on June 15, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K101683 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2010
Decision Date	October 25, 2010
Days to Decision	132 days
Submission Type	Abbreviated
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	NTI — Drug Metabolizing Enzyme Genotyping Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3360
Definition	Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System.