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)
Device Facts
| Record ID | K252306 |
|---|---|
| Device Name | 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) |
| Applicant | Steritec Products |
| Product Code | QVB · General Hospital |
| Decision Date | Apr 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2806 |
| Device Class | Class 2 |
Regulatory Classification
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.
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:
