# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products
- Decided: Apr 22, 2026 after 272 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 6.

## Indications for use
The Verrix EVA™ STEAM Biological Indicator (BI) 1200 in conjunction with the Verrix EVA™ Auto-reader 1100 is intended for routine monitoring of the steam sterilization process for the following cycles: * 270°F (132°C) 4 minutes dynamic air removal (Pre-Vac) steam sterilization cycles * 275°F (135°C) 3 minutes dynamic air removal (Pre-Vac) steam sterilization cycles When used in conjunction with the Verrix EVA™ Auto-reader 1100, the Verrix EVA™ STEAM Biological Indicator 1200 provides a sterilization confirmation result within 7 minutes. The Verrix EVA™ STEAM Biological Indicator (BI) 1200 is not recommended and should not be used for qualification testing purposes. The Verrix EVA™ STEAM Process Challenge Device (PCD) 1300 in conjunction with the Verrix EVA™ Auto-reader 1100 is intended for routine monitoring of the following sterilization cycles: * 270°F (132°C) 4 minutes dynamic air removal (Pre-Vac) steam sterilization cycles * 275°F (135°C) 3 minutes dynamic air removal (Pre-Vac) steam sterilization cycles When used in conjunction with the Verrix EVA™ Auto-Reader 1100, the Verrix EVA™ STEAM Biological Indicator 1200 contained in the PCD provides a sterilization confirmation result within 7 minutes. The Verrix EVA™ STEAM Process Challenge Device (PCD) 1300 is not recommended and should not be used for qualification testing purposes.

Source page: https://510kreport.com/device/K252306
Methodology: https://510kreport.com/methodology