Cleared Traditional

eSensor Warfarin Sensitivity Saliva Test

K152612 · Genmark Diagnostics, Incorporated · Chemistry

May 2016

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K152612 is an FDA 510(k) clearance for the eSensor Warfarin Sensitivity Saliva Test, a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II — Special Controls, product code ODW), submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on May 26, 2016, 255 days after receiving the submission on September 14, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K152612 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2015
Decision Date	May 26, 2016
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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.