# K093794: Smart-Read Eztest-Steam Scbi and Test Pack

- Pathway: 510(k) (Special)
- Applicant: Sgm Biotech, Inc.
- Decided: May 14, 2010 after 155 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801109 (1980). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930682: Eztest-Steam, Sgm Biotech, Inc. (1994) Summary page 1.
- K963841: Eztest, Sgm Biotech, Inc. (1997) Summary page 1.

## Most influential descendants
- K112018: Smart Read Eztest Steam (2012), 0 descendants of its own

## Recalls of this device
- Aug 2, 2013 · Class II · Z-1994-2013: AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameter
- Jun 4, 2013 · Class II · Z-1868-2013: Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims.

## Indications for use
Smart-Read EZTest - Steam self-contained biological indicators (SCBI) are for monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are established in accordance with USP 31 for the pre-vacuum 121'C steam process. Additional pre-vacuum saturated steam sterilization temperatures are also included in the Certificate of Analysis. Smart-Read EZTest - steam SCB1s are also appropriate for use in saturated steam processes of 1320 C, 1340 C and 1350 C. The Smart-Read EZTest - steam SCSIl is placed into a sterilizer load in a horizontal position in a location that is judged to be the most difficult to sterilize. A sterilization cycle appropriate for the particular type of load is run. Following the sterilization cycle, the operator removes the SCBI from the load and waits approximately 10 minutes until the device has cooled so it can be comfortably handled. The operator then activates the self-contained ampoule by placing it into the activation well in the Smart-Well incubator and gently pulling forward. This action mechanically flexes the side wall of the plastic vial to break the glass ampoule containing the culture medium. The activated Smart-Read EZTest - steam SCSI is then placed in an incubator at 60 + 20 C for 10 hours which provides conditions conducive to growth of any bacterial spores which might have survived the sterilization cycle. Microbial growth of the indicator organisms will produce acid in the microbiological culture medium containing bromcresol purple, thus lowering the pH of the solution and invoking a yellow color change of the media components. If sterilization conditions are met the spores have been killed and the media will remain clear and purple at the conclusion of the 10 hour incubation time.

Source page: https://510kreport.com/device/K093794
Methodology: https://510kreport.com/methodology