# K231383: Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

- Pathway: 510(k) (Traditional)
- Applicant: Terragene S.A.
- Decided: Sep 18, 2024 after 495 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® l00NX Sterilization System (Standard and Express cycles). • V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). • Sterizone® VP4 Sterilizer ( cycle 1 ). • LowTem Crystal 120 Sterilizer (Standard cycle). BT95 has rapid readout at 2 hours at 60 cc while BT96 has super rapid readout at 30 minutes at 60 cc. Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® 100NX Sterilization System (Standard and Express cycles). • V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). • Sterizone® VP4 Sterilizer ( cycle 1 ). • LowTem Crystal 120 Sterilizer (Standard cycle). The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® 100NX Sterilization System (Standard and Express cycles). • V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles). • Sterizone® VP4 Sterilizer ( cycle 1 ). • LowTem Crystal 120 Sterilizer (Standard cycle). The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K231383
Methodology: https://510kreport.com/methodology