Cleared Traditional

LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

K121399 · Luminex Corp. · Immunology

Jan 2013

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K121399 is an FDA 510(k) clearance for the LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P, a Instrumentation For Clinical Multiplex Test Systems (Class II — Special Controls, product code NSU), submitted by Luminex Corp. (Austin, US). The FDA issued a Cleared decision on January 9, 2013, 245 days after receiving the submission on May 9, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K121399 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2012
Decision Date	January 09, 2013
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Immunology (IM)
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