# DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

- Pathway: De Novo (Direct)
- Applicant: Terragene S.A.
- Decided: Jul 12, 2024 after 742 days
- Product code: QVB (Biological Sterilization Indicator With Indirect Growth Detection)
- Device class: 2
- Regulation: 21 CFR 880.2806
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K251559: InstaTRU Instant Biological Indicator for Steam (IBI-05) (2026), 0 descendants of its own
- 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) (2026), 0 descendants of its own

## Indications for use
Terragene® Bionova® Photon Biological Indicator (BT225) is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes. BT225 SCBI is not recommended and should not be used for qualification testing purposes. On each Terragene® Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam. - Gravity-displacement Steam Sterilization Cycles 132 ºC, 25 minutes 132 ºC, 15 minutes 132 ºC, 10 minutes 135 ºC, 10 minutes - Dynamic-air-removal Steam Sterilization Cycles 132 ºC, 4 minutes 135 ºC, 3 minutes Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60 °C and reads the Terragene® Bionova® Photon SCBIs at the times prescribed in the User Manual.

Source page: https://510kreport.com/device/DEN220042
Methodology: https://510kreport.com/methodology