Not Cleared Post-NSE

DEN040008 - CEDIA SIROLIMUS ASSAY (FDA 510(k) Clearance)

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

DEN040008 · Microgenics Corp. · Chemistry device
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Jul 2004
Decision
41d
Days
Class 2
Risk

DEN040008 is an FDA 510(k) submission (not cleared) for the CEDIA SIROLIMUS ASSAY. Classified as Sirolimus Test System (product code NRP), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Not Cleared (DENG) decision on July 28, 2004 after a review of 41 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3840 - 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.

View all Microgenics Corp. devices

Submission Details

510(k) Number DEN040008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 17, 2004
Decision Date July 28, 2004
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics

Device Classification

Product Code NRP Sirolimus Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3840
Definition Sirolimus Test Systems Are Intended For The Quantitative Measurement Of Sirolimus In Whole Blood As An Aid In Management Of Transplant Patients Taking This Sirolimus.
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.