# K052724: Teco Ise Reagent Set for CX System

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Dec 14, 2005 after 76 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Teco ISE Reagent Set is intended for quantitative measurement of Sodium, Potassium; Chloride and Carbon Dioxide in human serum samples on the Beckman CX System. Teco ISE Reagent Set is used in the diagnosis and treatment electrolyte disorders. ISE Buffer reagent is intended for quantitative measurement of Sodium, Potassium, and Chloride. ISE Reference Reagent is to provide reference points for Sodium, Potassium, and Chloride. The C02 Acid Reagent is to release Carbon Dioxide from serum samples. The C02 Buffer Reagent is to provide a reference point for Carbon Dioxide. This reagent set is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K052724
Methodology: https://510kreport.com/methodology