# K223755: i-STAT G cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Sep 11, 2023 after 270 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K883181 (1988). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2021) Summary page 4.

## Most influential descendants
- K252488: ABL90 FLEX PLUS System (2026), 0 descendants of its own

## Indications for use
The i-STAT G cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose in arterial, venous or capillary whole blood in point of care or clinical laboratory settings. Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K223755
Methodology: https://510kreport.com/methodology