# K082352: Serim Disintek Opa Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Sep 25, 2008 after 40 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 K070419 (2007). 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)
- K070419: Opaciden Opa Reagent Strips, Hach Company (2007) Summary page 1.

## Indications for use
The Serim® DISINTEKTM OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Metricide OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.

Source page: https://510kreport.com/device/K082352
Methodology: https://510kreport.com/methodology