Not Cleared Post-NSE

DEN040012 - AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN040012 · Affymetrix, Inc. · Toxicology device
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Dec 2004
Decision
50d
Days
Class 2
Risk

DEN040012 is an FDA 510(k) submission (not cleared) for the AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM. Classified as Instrumentation For Clinical Multiplex Test Systems (product code NSU), Class II - Special Controls.

Submitted by Affymetrix, Inc. (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2004 after a review of 50 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2570 - the FDA toxicology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Toxicology review framework.

View all Affymetrix, Inc. devices

Submission Details

510(k) Number DEN040012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 03, 2004
Decision Date December 23, 2004
Days to Decision 50 days
Submission Type Post-NSE
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics

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 Toxicology devices follow this clearance model.