21 CFR 880.2806 — Biological Sterilization Indicator With Indirect Growth Detection
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2806
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 2 | 2 |
Special Controls
QVB — Biological Sterilization Indicator With Indirect Growth Detection
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:
De Novo Order DEN220042
