# K251035: DISINTEK™ PA Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research
- Decided: Jun 3, 2025 after 61 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: 5 generations back to K914145 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152394: Rapicide PA High-Level Disinfectant Test Strips, Medivators, Inc. (2016) Summary page 5.

## Indications for use
The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.

Source page: https://510kreport.com/device/K251035
Methodology: https://510kreport.com/methodology