# K060108: Cobas Integra Chloride Elctrode Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 16, 2006 after 34 days
- Product code: CGZ (Electrode, Ion-Specific, 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: 2 generations back to K912649 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module, Roche Diagnostic Systems, Inc. (1996) Summary page 2.

## Indications for use
The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.

Source page: https://510kreport.com/device/K060108
Methodology: https://510kreport.com/methodology