# K230275: i-STAT CG8+ cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Oct 27, 2023 after 268 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: 4 generations back to K883181 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2020) Summary page 4.

## Indications for use
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings. The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings. Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.

Source page: https://510kreport.com/device/K230275
Methodology: https://510kreport.com/methodology