Not Cleared Post-NSE

DEN030002 - ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

DEN030002 is an FDA 510(k) submission for ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE, manufactured by Spectral Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code NGS cleared through the Post-NSE 510(k) pathway after a 63-day FDA review.

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.

FDA 510(k) Submission Details - DEN030002

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

NGS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NGS Assay, Endotoxin Activity, Chemiluminescent

Devices cleared under the same product code (NGS) and FDA review panel - the closest regulatory comparables to DEN030002.

Endotoxin Activity Assay (EAA)

K183176 · Spectral Medical, Inc. · Mar 2019

FDA 510(k) Resources - Microbiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of DEN030002

Spectral Diagnostics, Inc.

Rockville, MD · US

TOM TSAKERIS

Regulatory profile

12 submissions 11 cleared

92% clearance rate · Active in Microbiology

View all devices by Spectral Diagnostics, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: June 16, 2003. Record added to 510k Database: March 2026.

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