# K251559: InstaTRU Instant Biological Indicator for Steam (IBI-05)

- Pathway: 510(k) (Traditional)
- Applicant: True Indicating, LLC
- Decided: Jun 18, 2026 after 393 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
Longest line of descent: 1 generation back to DEN220042 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH), Terragene S.A. (2024) Summary page 5.

## Indications for use
The True Indicating Instant Biological Indicator for Steam (IBI-05) is a biological indicator inoculated with a minimum of 10”5 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes, and for monitoring processed loads, providing visual confirmation in 20 seconds. The IBI-05 is not recommended and should not be used for qualification testing purposes. Gravity-displacement Steam Sterilization Cycles: 121 °C for 30 minutes, 132 °C for 25 minutes, 132 °C for 15 minutes, 132 °C for 10 minutes, and 132 °C for 3 minutes. Dynamic-air-removal Steam Sterilization Cycles: 132 °C for 4 minutes and 135 °C for 3 minutes.

Source page: https://510kreport.com/device/K251559
Methodology: https://510kreport.com/methodology