DEN220042 is an FDA 510(k) submission for the Terragene Bionova Photon Biological Indicator (BT225). This device is classified as a Biological Sterilization Indicator With Indirect Growth Detection (Class II - Special Controls, product code QVB).
Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Not Cleared (DENG) decision on July 12, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2806. A Biological Sterilization Indicator With Indirect Growth Detection Capabilities Is A Device Intended For Use By A Healthcare Provider To Accompany Products Being Sterilized Through A Sterilization Process To Monitor The Adequacy Of Sterilization. Detection Of Surviving Microorganisms Is Accomplished By A Method Other Than Direct Detection Of Growth Or Growth Products..
| 510(k) Number | DEN220042 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 01, 2022 |
| Decision Date | July 12, 2024 |
| Days to Decision | 742 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QVB - Biological Sterilization Indicator With Indirect Growth Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2806 |
| Definition | A Biological Sterilization Indicator With Indirect Growth Detection Capabilities Is A Device Intended For Use By A Healthcare Provider To Accompany Products Being Sterilized Through A Sterilization Process To Monitor The Adequacy Of Sterilization. Detection Of Surviving Microorganisms Is Accomplished By A Method Other Than Direct Detection Of Growth Or Growth Products. |