Not Cleared Post-NSE

DEN030002 - ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (FDA 510(k) Clearance)

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

DEN030002 · Spectral Diagnostics, Inc. · Microbiology device
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Jun 2003
Decision
63d
Days
Class 2
Risk

DEN030002 is an FDA 510(k) submission (not cleared) for the ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE. Classified as Assay, Endotoxin Activity, Chemiluminescent (product code NGS), Class II - Special Controls.

Submitted by Spectral Diagnostics, Inc. (Rockville, US). The FDA issued a Not Cleared (DENG) decision on June 16, 2003 after a review of 63 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3210 - the FDA microbiology 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 Microbiology review framework.

View all Spectral Diagnostics, Inc. devices

Submission Details

510(k) Number DEN030002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 14, 2003
Decision Date June 16, 2003
Days to Decision 63 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics

Device Classification

Product Code NGS Assay, Endotoxin Activity, Chemiluminescent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3210
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.