Cleared Traditional

XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)

K130189 · Luminex Molecular Diagnostics, Inc. · Chemistry

May 2013

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K130189 is an FDA 510(k) clearance for the XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE), 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 May 21, 2013, 116 days after receiving the submission on January 25, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K130189 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2013
Decision Date	May 21, 2013
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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.