Cleared Special

xTAG CYP2D6 Kit v3

K170492 · Luminex Molecular Diagnostics, Inc. · Toxicology

Aug 2017

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K170492 is an FDA 510(k) clearance for the xTAG CYP2D6 Kit v3, a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on August 11, 2017, 175 days after receiving the submission on February 17, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K170492 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2017
Decision Date	August 11, 2017
Days to Decision	175 days
Submission Type	Special
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.