Cleared Traditional

K103112 - AFFYMETRIX GENE PROFILING REAGENTS (FDA 510(k) Clearance)

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

K103112 · Affymetrix, Inc. · Immunology device
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May 2011
Decision
195d
Days
Class 2
Risk

K103112 is an FDA 510(k) clearance for the AFFYMETRIX GENE PROFILING REAGENTS. Classified as Complete Gene Expression Profiling Accessory Reagents (product code OVA), Class II - Special Controls.

Submitted by Affymetrix, Inc. (Redwood Shores, US). The FDA issued a Cleared decision on May 4, 2011 after a review of 195 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2570 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Affymetrix, Inc. devices

Submission Details

510(k) Number K103112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2010
Decision Date May 04, 2011
Days to Decision 195 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 104d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVA Complete Gene Expression Profiling Accessory Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.2570
Definition Complete Gene Expression Profiling Accessory Reagent Kits Include All Components Necessary To Perform Transcript Synthesis, Fluorescent Labeling, And Detection And Are Intended To Carry Out All Processing Steps For Separately Cleared Gene Expression Microarray Assays Which Specify Their Use. They Are Designed And Optimized For Preparation Of Labeled Complementary Rna (crna) Target Using Total Rna Isolated From Specific Clinical Tissue Specimens For Hybridization To And Measurement Of Fluorescently-labeled Crna Targets Using A Specified And Cleared Microarray Instrumentation System. They May Also Include Specified Exogenous Controls Intended To Monitor Amplification And Labeling Processes.
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 Immunology devices follow this clearance model.