Cleared Traditional

ESENSOR WARFARIN SENSITIVITY SALIVA TEST

K110786 · GenMark Diagnostics, Inc. · Chemistry

Dec 2011

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K110786 is an FDA 510(k) clearance for the ESENSOR WARFARIN SENSITIVITY SALIVA TEST, a Instrumentation For Clinical Multiplex Test Systems (Class II — Special Controls, product code NSU), submitted by GenMark Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 2, 2011, 255 days after receiving the submission on March 22, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K110786 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2011
Decision Date	December 02, 2011
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NSU — Instrumentation For Clinical Multiplex Test Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.2570
Definition	Instrumentation For Clinical Multiplex Test Systems Is A Device That Is Intended To Measure And Sort Multiple Signals Generated By An Assay From A Clinical Sample. The Generated Signals From Multiple Probes Or Other Ligands May Be Measured By Fluorescence, Luminescence, Or Other Physical Or Chemical Properties. The Device May Integrate Scanning, Reagent Handling, Hybridization, Washing, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. This Instrumentation Is Used With Specific Assays To Comprise An Assay Test System To Measure Multiple Analytes Of A Similar Chemical Nature For De