Cleared Traditional

XTAG CYP2C19 KIT V3

K131565 · Luminex Molecular Diagnostics, Inc. · Toxicology

Sep 2013

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K131565 is an FDA 510(k) clearance for the XTAG CYP2C19 KIT V3, a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Luminex Molecular Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on September 11, 2013, 104 days after receiving the submission on May 30, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K131565 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2013
Decision Date	September 11, 2013
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

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.