# K221641: Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

- Pathway: 510(k) (Traditional)
- Applicant: Terragene S.A.
- Decided: Feb 28, 2023 after 267 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® Hyper Biological Indicator (BT98) is a self-contained biological indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of Plasma or Vaporized Hydrogen Peroxide sterilization processes in the following systems: -Sterrad® 100S Sterilization System. -Sterrad® NX Sterilization System (Standard and Advanced Cycles). -Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced Cycles). -Sterrad® l00NX Sterilization System (Standard, Flex, Express and Duo Cycles). -Sterrad® lO0NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo Cycles). -V-Pro® S2 Low Temperature Sterilization System (Fast, Non Lumen, Lumen and Flexible Cycles). -V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible Cycles). Terragene® Bionova® BT98 has Hyper Rapid readout at 5 minutes at 60 °C. Terragene® Bionova® Hyper Auto-reader Incubator (BHY) incubates at 60 °C and reads the Terragene® Bionova® Hyper SCBis at the times prescribed in the User Manual. Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) incubates at 60 °C and reads the Bionova® SCBis at the times prescribed in the User Manual.

Source page: https://510kreport.com/device/K221641
Methodology: https://510kreport.com/methodology