QVB · Biological Sterilization Indicator With Indirect Growth Detection
General Hospital · 21 CFR 880.2806 · Class 2
Overview
| Product Code | QVB |
|---|---|
| Device Name | Biological Sterilization Indicator With Indirect Growth Detection |
| Regulation | 21 CFR 880.2806 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
The Terragene Bionova Photon Biological Indicator (BT225) and Terragene Bionova Photon Auto-Reader Incubator (BPH) is a biological sterilization indicator with indirect growth detection. It is a self-contained biological indicator (SCBI) inoculated with Geobacillus stearothermophilus spores, intended for routine monitoring of the efficacy of steam sterilization processes (gravity-displacement and dynamic-air-removal cycles). The system uses fluorescence technology to provide a 7-second readout of sterilization efficacy.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the identified risks.
Special Controls
In combination with the general controls of the FD&C Act, the biological sterilization indicator with indirect growth detection is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252306 | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | Steritec Products | Apr 22, 2026 | SESE |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. | Jul 12, 2024 | DENG |
Top Applicants
- Steritec Products — 1 clearance
- Terragene S.A. — 1 clearance
