# K153357: i-STAT Alinity System with i-STAT Sodium test

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Jul 8, 2016 after 231 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: 2 generations back to K001387 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103195: I-Stat 1 Wireless Analyzer, Abbott Point of Care, Inc. (2011) Summary page 4.

## Indications for use
The i-STAT Alinity System with i-STAT Sodium test is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity System with Sodium test is intended for the quantitative measurement of sodium in arterial and venous whole blood. Sodium measurements are used for monitoring electrolyte imbalances. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K153357
Methodology: https://510kreport.com/methodology