# K113302: Namsa Steam Self-Contained Biological Indicators

- Pathway: 510(k) (Abbreviated)
- Applicant: North American Science Assoc., Inc.
- Decided: Jan 20, 2012 after 73 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Attest Product Code 1262/1262P (Pre-amendment): named in the summary without a submission number

## Indications for use
The NAMSA SOBI is intended for use in monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are for pre-vacuum and gravity displacement 12100C steam processes. Additional saturated steam sterilization temperatures are also included on the Certificate of Analysis. NAMSA Steam SCBls are also appropriate for use in saturated steam processes of 1320C, 134 C and 135 C. Exposure times at 121 0OC are 30 minutes and 3 minutes for exposures at 13200, 134CC and 13500. Reference the sterilizer user manual for specific exposure timeframes. The NAMSA Steam SCBls are placed into a sterilization load in a location that has been determined to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. The SOBI is removed after the cycle is complete and has cooled to a point where the SCBI can comfortably be handled. The SCBI is activated by pushing the sides with enough force to break the ampoule containing the growth medium. The activated SCBI is incubated at 58-620C for 24 hours. A reduced incubation time of 24 hours has been validated.

Source page: https://510kreport.com/device/K113302
Methodology: https://510kreport.com/methodology