Cleared Traditional

FLEXMAP 3D

K133302 · Luminex Corp. · Pathology

Jan 2014

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K133302 is an FDA 510(k) clearance for the FLEXMAP 3D, 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 10, 2014, 77 days after receiving the submission on October 25, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K133302 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2013
Decision Date	January 10, 2014
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Pathology (PA)
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