# K151482: BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Bcr Diagnostics, Inc.
- Decided: Feb 26, 2016 after 269 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 K926364 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090569: Modification to: Attest Rapid Readout Biological Indicator, Mode 1292, 3M Company (2009) Summary page 4.
- K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader, 3M Company-3M Health Care (2011) Summary page 4.

## Indications for use
Use the BCR-30-min BI™ and the RBIP-ST30™ together for momitoring performance of gravity displacement steam sterilization cycles of 30 mmutes at 250°F (121°C). The BCR-30-min BI™ m conjunction with the RBIP-ST30™ provides final fluorescence results in 30 mmutes.

Source page: https://510kreport.com/device/K151482
Methodology: https://510kreport.com/methodology