# K222167: E-Z Chek Chlorine Residual Test Strips (K100-0101B)

- Pathway: 510(k) (Traditional)
- Applicant: Reprocessing Products Corporation (Rpc)
- Decided: Oct 18, 2022 after 89 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 K901734 (1990). 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)
- K901734: Serim Residual Chlorine Test Kit, Serim Research Corp. (1990) Summary page 4.

## Indications for use
E-Z Chek@ Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between Oppm and 5ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).

Source page: https://510kreport.com/device/K222167
Methodology: https://510kreport.com/methodology
