# K081600: Steris Resert XL Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Aug 22, 2008 after 77 days
- Product code: JOJ (Indicator, Physical/Chemical 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: 2 generations back to K910320 (1991). 4 ancestors in all.
8 later devices descend from it; 2 cite 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)
- K972035: Sporox Test Strips, Serim Research Corp. (1997) Summary page 2.
- K012335: Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30 Solutions, Albert Browne, Ltd. (2001) Summary page 2.

## Most influential descendants
- K102217: System 1E Chemical Indicator (2010), 5 descendants of its own
- K173428: VERIFY Chemical Indicator for S40 Sterilant (2018), 3 descendants of its own
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS (2024), 1 descendant of its own
- K102296: Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2) (2011), 1 descendant of its own
- K243475: Chemical Indicator for enspire CLCSPS (LCC015) (2024), 0 descendants of its own

## Indications for use
The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resento XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert ® XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%. The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.

Source page: https://510kreport.com/device/K081600
Methodology: https://510kreport.com/methodology