Cleared Traditional

K163652 - ePlex Instrument (FDA 510(k) Clearance)

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

K163652 · Genmark Diagnostics, Incorporated · Microbiology device
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Jun 2017
Decision
168d
Days
Class 2
Risk

K163652 is an FDA 510(k) clearance for the ePlex Instrument. Classified as Instrumentation For Clinical Multiplex Test Systems (product code NSU), Class II - Special Controls.

Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on June 9, 2017 after a review of 168 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2570 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Genmark Diagnostics, Incorporated devices

Submission Details

510(k) Number K163652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date June 09, 2017
Days to Decision 168 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 102d · This submission: 168d
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 Microbiology devices follow this clearance model.