Not Cleared Post-NSE

DEN130011 - ILLUMINA MISEQDX PLATFORM (FDA 510(k) Clearance)

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

DEN130011 · Illumina, Inc. · Chemistry device
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Nov 2013
Decision
57d
Days
Class 2
Risk

DEN130011 is an FDA 510(k) submission (not cleared) for the ILLUMINA MISEQDX PLATFORM. Classified as High Throughput Dna Sequence Analyzer (product code PFF), Class II - Special Controls.

Submitted by Illumina, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on November 19, 2013 after a review of 57 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2265 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework.

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Submission Details

510(k) Number DEN130011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 23, 2013
Decision Date November 19, 2013
Days to Decision 57 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics

Device Classification

Product Code PFF High Throughput Dna Sequence Analyzer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.2265
Definition A High Throughput Sequencing Technology Performing Targeted Dna Sequencing Of Amplicons From A Defined Genetic Region Or A Subset Of Genes In Human Genomic Dna From A Clinical Sample.
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 Chemistry devices follow this clearance model.