# K140373: Ise Indirect NA, K, C1 for Gen 2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 22, 2014 after 97 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
Longest line of descent: 3 generations back to K912649 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123726: Cobas 8000 Ise Indirect NA, K, CI for Gen. 2, Roche Diagnostics (2013) Summary page 3.

## Indications for use
The cobas 8000 ISE module is a fully automated ion-specific analyzer intended for the in vitro potentiometric determination of chloride, potassium, and sodium in serum, plasma, and urine using ion-selective electrodes. Measurements obtained by this device are used in the diagnosis and treatment of diseases or conditions involving electrolyte imbalance.

Source page: https://510kreport.com/device/K140373
Methodology: https://510kreport.com/methodology