# K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 24, 1996 after 43 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 K912649 (1991). 4 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912648: ISE/NA+, Boehringer Mannheim Corp. (1991) Summary page 3.
- K912649: ISE/K+, Boehringer Mannheim Corp. (1991) Summary page 3.
- K912647: ISE/CI-, Boehringer Mannheim Corp. (1991) Summary page 3.
- K924488: Kodak Ektachem Clinical Chemistry Slides (LI), Eastman Kodak Company (1993) Summary page 3.

## Most influential descendants
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) (2005), 15 descendants of its own
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K123726: Cobas 8000 Ise Indirect NA, K, CI for Gen. 2 (2013), 1 descendant of its own
- K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (2012), 1 descendant of its own

## Indications for use
The COBAS INTEGRA ISE module applications are intended for use for the quantitative determination of sodium, potassium, chloride, and lithium concentrations using ion-selective electrodes: the direct application is intended for undiluted serum and plasma the indirect application is intended for diluted serum and plasma (does not include lithium) the urine application is intended for diluted urine (does not include lithium)

Source page: https://510kreport.com/device/K963627
Methodology: https://510kreport.com/methodology