# K223023: Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

- Pathway: 510(k) (Traditional)
- Applicant: Plasmapp Co,., Ltd.
- Decided: May 9, 2023 after 222 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
Longest line of descent: 2 generations back to K191021 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212193: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), Plasmapp Co,., Ltd. (2021) Summary page 6.

## Indications for use
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 1 Q/'6 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60° C. Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60 ° C and 37 ° C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals. Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 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. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide. The self-contained biological indicator and chemical processing indicators are intended for use with the STERLINK™ FPS-15s Plus when operating in pouch plus mode and chamber mode.

Source page: https://510kreport.com/device/K223023
Methodology: https://510kreport.com/methodology