# K183688: 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: 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: 3 generations back to K883181 (1988). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 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
- K230275: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 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 sodium, potassium, chloride and blood urea nitrogen in arterial or venous 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. Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders. Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K183688
Methodology: https://510kreport.com/methodology