# K992341: Cidex Opa Solution Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Nov 23, 1999 after 133 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: 1 generation back to K915170 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915170: Pymah Cold Sterilog Glutaraldehyde Monitor, Pymah Corp. (1992) Summary page 1.

## Indications for use
CIDEX* OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of active ingredient in CIDEX* OPA Solution is above or below the minimum effective concentration of 0.3% OPA. CIDEX* OPA Solution Test Strips cannot be used to validate the sterilization or disinfection process.

Source page: https://510kreport.com/device/K992341
Methodology: https://510kreport.com/methodology