# K141580: Sterizone Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: Dec 17, 2014 after 187 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: 6 generations back to K994055 (2002). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123017: Sterrad Cyclesure 24 Biological Indicator Model 14324, Advanced Sterilization Products (2012) Summary page 4.
- K111391: Sterrad (R) 100NX Duo Cycle Test Pack, Advanced Sterilization Products (2012) Summary page 4.
- K090514: Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes, STERIS Corporation (2009) Summary page 4.

## Most influential descendants
- K203560: STERIZONE VP4 Test Pack (2021), 0 descendants of its own

## Indications for use
The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle (“Cycle 17). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H,0, or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration. STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Self-contained Biological Indicator (TSO; product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). An external STERIZONE® CI+ Chemical Indicator (TSO;3 product code 43810) is also added to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items. The STERIZONE® VP4 Test Pack is constructed by first inserting the STERIZONE® BI+ Self- contained Biological Indicator inside the syringe, with the SCBI cap facing to the Luer-lock of the syringe. The plunger is then inserted to the 10 mL mark of the syringe. The diffusion restrictor is screwed to the Luer-lock of the syringe. The chemical indicator is then inserted in the opening between the plunger and the syringe. The test pack is placed within the load on the upper shelf of the STERIZONE® VP4 Sterilizer loading rack. After processing, the SCBI is retrieved from the test pack. The SCBI is intended to provide users with a means to assess spore kill by the STERIZONE® VP4 Sterilizer. A “no growth” result from the SCBI after 18 hours of incubation indicates that the process achieved the conditions necessary to kill at least 1 x 10 viable spores of Geobacillus stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier.

Source page: https://510kreport.com/device/K141580
Methodology: https://510kreport.com/methodology