# K991675: Modification of: Sterrad BI Test Pack

- Pathway: 510(k) (Special)
- Applicant: Advanced Sterilization Products
- Decided: Jun 15, 1999 after 29 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: 1 generation back to K921909 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921909: Sterrad BI Test Pack, Johnson & Johnson Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K993775: Sterrad BI Test Pack (2000), 0 descendants of its own

## Indications for use
The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® 100 Sterilizer cycle*, It functions as a routine test pack with both a biological sterilization process indicator and a chernical process indicator. Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization. * See precautionary statement in Instructions For Use concemning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows: NOTE: The Certificate of Performance that accompanies these BI Test Packs contains data from the STERRAD® 100 Sterilizer. This information is unique to the STERRAD® 100 Sterilizer. The initial validation data submitted, based upon varying hydrogen peroxide concentration in the STERRAD® 50 Sterilizer, indicate that the BI Test Pack is acceptable for use with the STERRAD® 50 Sterilizer. The final performance data (D-value and Survival/Kill times) are not yet complete. Updated performance data for the BI Test Pack in the STERRAD® 50 Sterilizer will be provided by ASP as soon as it is available.

Source page: https://510kreport.com/device/K991675
Methodology: https://510kreport.com/methodology