# K183678: i-STAT CHEM8+ cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Feb 7, 2020 after 406 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: 3 generations back to K883181 (1988). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042291: Unicel DXC 600 and 800 Synchron Systems, Beckman Coulter, Inc. (2004) Summary page 5.

## Most influential descendants
- K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2021), 3 descendants of its own
- K223755: i-STAT G cartridge with the i-STAT 1 System (2023), 1 descendant of its own
- K252488: ABL90 FLEX PLUS System (2026), 0 descendants of its own
- K223710: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 0 descendants of its own

## Indications for use
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose, and creatinine in arterial or venous 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K183678
Methodology: https://510kreport.com/methodology