# K113221: Namsa Biological Indicator Spore Strips

- Pathway: 510(k) (Traditional)
- Applicant: North American Science Assoc., Inc.
- Decided: Apr 27, 2012 after 178 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 K912796 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912796: Spore Strip, Raven Biological Laboratories, Inc. (1992) Summary page 1.
- K020026: Raven Bacterial Spore Strips, Raven Biological Laboratories, Inc. (2002) Summary page 1.
- K050591: Modification to Raven Bacterial Spore Strips, Raven Biological Laboratories, Inc. (2005) Summary page 1.

## Indications for use
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCCO 7953, or dual species Geobacillus steamthermophilus ATCCO 7953 and Bacillus atmophaeus ATCCe 9372). is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species. Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 1210 C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 550C for 2 hours, 10 minutes. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.

Source page: https://510kreport.com/device/K113221
Methodology: https://510kreport.com/methodology