# K081370: Serim Disintek Opa Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Jul 11, 2008 after 57 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: 2 generations back to K922481 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991709: Browne Cidex Opa Indicator, Albert Browne, Ltd. (1999) Summary page 1.

## Most influential descendants
- K202565: WAVICIDE-OPA MEC Indicator (2020), 0 descendants of its own
- K120652: Rapicide Opa-28 Test Strip (2012), 0 descendants of its own

## 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 Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.

Source page: https://510kreport.com/device/K081370
Methodology: https://510kreport.com/methodology