# K163646: Terragene Bionova (R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova (R) IC10/20FR Reader Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Terragene S.A.
- Decided: Nov 2, 2017 after 314 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K251122: Terragene® Bionova® BT20 Biological Indicator (2025), 0 descendants of its own

## Recalls of this device
- Jan 15, 2025 · Class II · Z-1248-2025: Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
- Dec 7, 2023 · Class II · Z-0837-2024: Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

## Indications for use
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam. Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes. Terragene Bionova® IC10/20FR Reader Incubator incubates at 60 ©C and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT223), 1 hour (BT221, BT222), and 3 hours (BT220) Models | 121°C | 1320C | 1359C Gravity Displacement BT220, BT222, PCD220-C, PCD220-2, PCD222-C, PCD222-2 | 30 minutes 15 minutes, 10 minutes 25 minutes BT221, BT223 | NA | 130 minutes, 3 minutes, minutes 10 minutes Dynamic Air Removal (Vacuum Assist) BT220, BT222, PCD220-C, PCD220-2, PCD222-C, PCD222-2 | NA | 4 minutes 3 minutes Models | Fluorescence Read Time | pH Color Change BT221, BT222, PCD222-C, PCD222-2 | 1 hour | 48 Hours BT223 | 30 minutes | 48 Hours BT220, PCD220-C, PCD220-2 | 3 hours | 48 Hours

Source page: https://510kreport.com/device/K163646
Methodology: https://510kreport.com/methodology