Not Cleared Post-NSE

SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT (DEN110002) - FDA 510(k) Clearance

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

DEN110002 · STERIS Corporation · General Hospital
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Mar 2012
Decision
242d
Days
Class 2
Risk

DEN110002 is an FDA 510(k) submission (not cleared) for the SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT. Classified as Liquid Chemical Processing System (product code OVY), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Not Cleared (DENG) decision on March 30, 2012 after a review of 242 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6887 - the FDA general hospital 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 General Hospital review framework.

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Submission Details

510(k) Number DEN110002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 01, 2011
Decision Date March 30, 2012
Days to Decision 242 days
Submission Type Post-NSE
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 129d · This submission: 242d
Pathway characteristics

Device Classification

Product Code OVY Liquid Chemical Processing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6887
Definition The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring.
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 General Hospital devices follow this clearance model.