Cleared Traditional

K133302 - FLEXMAP 3D (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133302 · Luminex Corp. · Pathology device
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Jan 2014
Decision
77d
Days
Class 2
Risk

K133302 is an FDA 510(k) clearance for the FLEXMAP 3D. Classified as Instrumentation For Clinical Multiplex Test Systems (product code NSU), Class II - Special Controls.

Submitted by Luminex Corp. (Austin, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2570 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Luminex Corp. devices

Submission Details

510(k) Number K133302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 77d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NSU Instrumentation For Clinical Multiplex Test Systems
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.