# K120652: Rapicide Opa-28 Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Oct 12, 2012 after 224 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)
- K081370: Serim Disintek Opa Test Strip, Serim Research Corp. (2008)

## Indications for use
The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.

Source page: https://510kreport.com/device/K120652
Methodology: https://510kreport.com/methodology