Terragene Bionova BT20 Biological Indicator
by Terragene 510(k)
Active
510(k) K251122
Overview
The Terragene Bionova BT20 Biological Indicator is a self-contained biological indicator (SCBI) for steam sterilization, classified as a Class II device. It is designed to verify the effectiveness of steam sterilization cycles, utilizing Geobacillus stearothermophilus (ATCC 7953) spores to detect microbial survival after exposure to sterilization conditions.
This single-use device consists of a polypropylene tube containing a paper spore carrier and a glass ampoule of purple culture medium with a pH indicator. It is intended for use in gravity-displacement and vacuum-assisted steam sterilization cycles at temperatures between 121°C and 135°C. After sterilization, the indicator is incubated for 24 hours at 60 ± 2°C, where a color change from purple to another hue confirms the absence of microbial growth, indicating a successful sterilization process. The device holds FDA 510(k) clearance (K251122) and is regulated under 21 CFR 880.2800 for biological indicators.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251122 | Date4 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRC
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of steam sterilization cycles is the Terragene Bionova BT20 Biological Indicator designed to validate, and why is this important for my facility?
The Terragene Bionova BT20 is specifically designed to verify gravity-displacement and vacuum-assisted steam sterilization cycles at temperatures between 121°C and 135°C. This matters because it ensures your sterilization process meets the required conditions to kill *Geobacillus stearothermophilus* spores, a robust biological indicator of microbial survival. Validating these cycles helps confirm the effectiveness of your sterilization equipment and protocols, reducing the risk of contaminated medical devices.
Is the Terragene Bionova BT20 Biological Indicator reusable, and if not, how should it be handled after use?
The Terragene Bionova BT20 is a single-use device, meaning it should not be reused. After sterilization, the indicator must be incubated for 24 hours at 60 ± 2°C to assess microbial growth. If a color change occurs (from purple to another hue), it confirms the absence of surviving spores, and the indicator should be discarded. Reusing it could compromise sterility validation and introduce contamination risks.
How do I know if the Terragene Bionova BT20 Biological Indicator is sterile before use, and what should I expect when it’s exposed to a sterilization cycle?
The indicator is not sterile before use—its purpose is to detect microbial survival after sterilization. It contains *Geobacillus stearothermophilus* spores, which are intentionally present to challenge the sterilization process. After exposure to a valid steam cycle (121°C–135°C), the spores are killed if the process is effective. The indicator’s purple culture medium then remains unchanged, signaling successful sterilization, while any color shift after incubation indicates microbial growth and a failed cycle.
What storage conditions are recommended for the Terragene Bionova BT20 Biological Indicator, and why are these important?
The device data does not specify storage conditions, but as a self-contained biological indicator with spores and a pH-sensitive medium, it should be stored in a cool, dry place away from direct sunlight or extreme temperatures to preserve spore viability and indicator integrity. Proper storage ensures the indicator remains functional when used, providing accurate results for sterilization validation. Avoid refrigeration unless manufacturer guidelines (not provided here) explicitly recommend it.