# K053165: Ise Indirect NA, K, CL for Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 14, 2005 after 30 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: 1 generation back to K953239 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer, Boehringer Mannheim Corp. (1995) Summary page 2.

## Most influential descendants
- K132418: Cobas C 501 Ise Indirect NA, K, CL for Gen. 2 (2013), 0 descendants of its own

## Indications for use
The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Source page: https://510kreport.com/device/K053165
Methodology: https://510kreport.com/methodology