DEN230085 is an FDA 510(k) submission for the VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator. This device is classified as a Qualitative Cleaning Process Protein Indicator (Class II - Special Controls, product code SDC).
Submitted by Steris (Mentor, US). The FDA issued a Not Cleared (DENG) decision on November 12, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6930. 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..
| 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 | — |
| Product Code | SDC — Qualitative Cleaning Process Protein Indicator |
| Device Class | Class II - 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. |