# K141244: Namsa Biological Indicator Spore Strips (Dual Species) Namsa Biological Indicator Spore Strips (Single Species)

- Pathway: 510(k) (Traditional)
- Applicant: North American Science Assoc., Inc.
- Decided: Sep 9, 2014 after 118 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 4.
- K020026: Raven Bacterial Spore Strips, Raven Biological Laboratories, Inc. (2002) Summary page 4.
- K050591: Modification to Raven Bacterial Spore Strips, Raven Biological Laboratories, Inc. (2005) Summary page 4.

## Indications for use
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, product code STS-05R, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophacus ATCC® 9372, product code STNS-65R) is intended for use in testing the efficacy of chemiclave sterilization. Performance characteristics are established for exposure at 132°C for 20 minutes in a MDT Harvey Chemiclave model EC5500 chemiclave sterilizer. Vapo-Steril Solution is the sterilant utilized in the MDT Harvey Chemiclave sterilizer. The solution was cleared under 510(k) number K984270. The validation load used for evaluation of the device performance characteristics consisted of stainless steel dental instruments in a wrapped tray with a mass of 1 kg. A reduced incubation time of 72 hours for chemiclave sterilization at 132°C has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple and incubated at 58° - 62°C.

Source page: https://510kreport.com/device/K141244
Methodology: https://510kreport.com/methodology