# K081427: Browne Opa Test Strip

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Jun 11, 2008 after 21 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 2.

## Most influential descendants
- K241344: MetriCide™ OPA Plus Solution Test Strip (2024), 0 descendants of its own
- K181472: AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor (2019), 0 descendants of its own

## Indications for use
The Browne OPA Test Strip is a concentration monitor for use in ortho-phthalaldehyde-containing germicide solutions with a minimum effective concentration of 0.3%. The Browne OPA Test Strip is dedicated for use with CidexTM OPA solution

Source page: https://510kreport.com/device/K081427
Methodology: https://510kreport.com/methodology