Not Cleared Post-NSE

QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (DEN000007) - FDA 510(k) Clearance

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

DEN000007 · Inova Diagnostics, Inc. · Immunology device
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Aug 2000
Decision
29d
Days
Class 2
Risk

DEN000007 is an FDA 510(k) submission (not cleared) for the QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA. Classified as Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (product code NBT), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on August 16, 2000 after a review of 29 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5785 - the FDA immunology 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 Immunology review framework.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number DEN000007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 18, 2000
Decision Date August 16, 2000
Days to Decision 29 days
Submission Type Post-NSE
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics

Device Classification

Product Code NBT Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5785
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.