# K231746: VERIFY Spore Test Strip for S40 Sterilant Concentrate

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Sep 11, 2023 after 88 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: 2 generations back to DEN110002 (2012). 2 ancestors in all.
1 later device descends 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)
- K180553: VERIFY Spore Test Strip for S40 Sterilant, STERIS Corporation (2018) Summary page 5.

## Most influential descendants
- 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 Concentrate 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 and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A “no growth” result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

Source page: https://510kreport.com/device/K231746
Methodology: https://510kreport.com/methodology