Not Cleared Direct

DEN230085 - VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator (FDA 510(k) Clearance)

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

DEN230085 · Steris · General Hospital
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Nov 2024
Decision
330d
Days
Class 2
Risk

DEN230085 is an FDA 510(k) submission (not cleared) for the VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator. Classified as Qualitative Cleaning Process Protein Indicator (product code SDC), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Not Cleared (DENG) decision on November 12, 2024 after a review of 330 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6930 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 330 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN230085 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 18, 2023
Decision Date November 12, 2024
Days to Decision 330 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 128d · This submission: 330d
Pathway characteristics

Device Classification

Product Code SDC Qualitative Cleaning Process Protein Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6930
Definition A Qualitative Cleaning Process Protein Indicator Is Intended For Use By A Health Care Provider On A Cleaned Medical Device As An Interim Step Prior To High Level Disinfection Or Sterilization Of The Cleaned Medical Device. The Intended Use Is To Inform The Health Care User Of The Presence Of Residual Soil Protein In The Sample Extract.
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.