# K152394: Rapicide PA High-Level Disinfectant Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Medivators, Inc.
- Decided: Mar 11, 2016 after 200 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: 4 generations back to K914145 (1994). 10 ancestors in all.
2 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)
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant, Medivators Reprocessing Systems (2009) Summary page 5.
- K964264: High Range Peroxide Test Strip, Integrated Biomedical Technology, Inc. (1997) Summary page 5.
- K931935: Endpoint 500 Peracetic Acid Test Indicators, Minntech Corp. (1994) Summary page 5.

## Most influential descendants
- K251035: DISINTEK™ PA Test Strips (2025), 0 descendants of its own
- K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118 (2025), 0 descendants of its own

## Indications for use
The Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.

Source page: https://510kreport.com/device/K152394
Methodology: https://510kreport.com/methodology