# K241344: MetriCide™ OPA Plus Solution Test Strip

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Jun 11, 2024 after 29 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 K922481 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081427: Browne Opa Test Strip, STERIS Corporation (2008) Summary page 6.

## Indications for use
MetriCide OPA Plus Solution Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in MetriCide OPA Plus Solution, is above or below the Minimum Recommended Concentration (MRC) of 0.3% established for MetriCide OPA Plus Solution.

Source page: https://510kreport.com/device/K241344
Methodology: https://510kreport.com/methodology