Cleared Traditional

LUMINEX LX 100/200 INSTRUMENT

K073506 · Luminex Corp. · Chemistry

Mar 2008

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K073506 is an FDA 510(k) clearance for the LUMINEX LX 100/200 INSTRUMENT, a Instrumentation For Clinical Multiplex Test Systems (Class II — Special Controls, product code NSU), submitted by Luminex Corp. (Toronto, CA). The FDA issued a Cleared decision on March 7, 2008, 85 days after receiving the submission on December 13, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K073506 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2007
Decision Date	March 07, 2008
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

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