# K102217: System 1E Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Nov 22, 2010 after 108 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: 3 generations back to K910320 (1991). 7 ancestors in all.
5 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)
- K081600: Steris Resert XL Test Strip, STERIS Corporation (2008) Summary page 2.
- K063285: Reliance CI Process Indicator, Albert Browne, Ltd. (2007) Summary page 2.

## Most influential descendants
- 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
- K243475: Chemical Indicator for enspire CLCSPS (LCC015) (2024), 0 descendants of its own
- K233654: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (2023), 0 descendants of its own
- K230558: Revital-Ox PAA High Level Disinfectant Chemical Indicator (2023), 0 descendants of its own

## Indications for use
The Verify® SYSTEM 1E Chemical Indicator (SYSTEM IE Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEM I E Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate. The unprocessed Verify® SYSTEM IE Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.

Source page: https://510kreport.com/device/K102217
Methodology: https://510kreport.com/methodology