# K121823: Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric

- Pathway: 510(k) (Traditional)
- Applicant: Wescor, Inc.
- Decided: Mar 27, 2013 after 279 days
- Product code: JFS (Coulometric, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- 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 K760394 (1976). 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)
- K760394: Reagent, Chloridometer Acid, Bulcher Instruments (1976) Summary page 2.

## Indications for use
The Wescor ChloroChek Chloridometer test system is intended for the quantitative in vitro diagnostic determination of chloride in human sweat using the principle of coulometric titration. Sweat chloride measurements are used in the diagnosis of Cystic Fibrosis. It is for use in Clinical Laboratory settings. The Wescor ChloroChek Chloridometer test system consists of the ChloroChek Chloridometer and the ChloroChek Reagent Set. The ChloroChek Reagent Set (SS-248) is to be used on the ChloroChek. It is used as the titration matrix during the titration process. The 100 mmol/L NaCl/H2O Standard Solution (SS-251), is to be used on the ChloroChek. It is used as a calibration verifier, and quality control solution. The Wescor Sweat Controls (SS-150), levels #1,#2, and #3, are to be used on the ChloroChek. They are used as quality control solutions.

Source page: https://510kreport.com/device/K121823
Methodology: https://510kreport.com/methodology