# K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Aug 13, 2021 after 135 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: 4 generations back to K883181 (1988). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183678: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2020) Summary page 5.
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2020) Summary page 5.
- K191298: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2020) Summary page 5.
- K191360: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2020) Summary page 5.
- K183680: i-STAT CHEM8+ cartridge with the i-STAT 1 System, Abbott Point of Care, Inc. (2020) Summary page 5.

## Most influential descendants
- 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 sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide 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. Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. 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. Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases. 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. Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates. Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K210958
Methodology: https://510kreport.com/methodology