# K070419: Opaciden Opa Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Hach Company
- Decided: Aug 31, 2007 after 199 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Browne Cidex OPA Indicator: named in the summary without a submission number

## Most influential descendants
- K082352: Serim Disintek Opa Test Strip (2008), 0 descendants of its own

## Indications for use
The Opaciden OPA Solution Test Strips are a concentration monitor dedicated for use in ortho-pphthalaldehyde-conltaiflinlg germicide solutions with a minimum recommended concentration of 0.3%. The Opaciden OPA Solution Test Strips are dedicated for use with the Cidel Opaciden OPA Solution.

Source page: https://510kreport.com/device/K070419
Methodology: https://510kreport.com/methodology