# K132344: E-Z Check Ozone Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Reprocessing Products Corporation (Rpc)
- Decided: Feb 25, 2014 after 211 days
- Product code: MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant)
- Device class: 2
- Regulation: 21 CFR 876.5665
- 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 DEN120001 (2012). 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)
- DEN120001: Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase, Phadia US, Inc. (2012). Our reading of the summary gave K100106, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120001, Immunocap Tryptase, Calibrators, Curve Control, Conjugate… (Phadia US, Inc.), granted Feb 15, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Cited in the summary but kept off the family tree
- K100118: Ultra Low Total Chlorine. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.

Source page: https://510kreport.com/device/K132344
Methodology: https://510kreport.com/methodology