# K180553: VERIFY Spore Test Strip for S40 Sterilant

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 29, 2018 after 89 days
- Product code: OVY (Liquid Chemical Processing System)
- Device class: 2
- Regulation: 21 CFR 880.6887
- 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 DEN110002 (2012). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN110002: System 1E Process Biological Monitoring Kit, STERIS Corporation (2012) Summary page 5.

## Most influential descendants
- K231746: VERIFY Spore Test Strip for S40 Sterilant Concentrate (2023), 1 descendant of its own
- K233682: VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE (2023), 0 descendants of its own

## Indications for use
The VERIFY® Spore Test Strip for S40 Sterilant is intended to provide users with a means to assess spore kill by S40 sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A “no growth” result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.

Source page: https://510kreport.com/device/K180553
Methodology: https://510kreport.com/methodology