← Product Code [QVB](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QVB) · 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) (K252306)

_Steritec Products · QVB · Apr 22, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QVB/K252306

## Device Facts

- **Applicant:** Steritec Products
- **Product Code:** [QVB](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QVB.md)
- **Decision Date:** Apr 22, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.2806
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory 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.

## Special Controls

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:

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QVB/K252306](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QVB/K252306)

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