i-STAT CG4+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc.The i-STAT CG4+ cartridge with the i-STAT 1 System by Abbott Point of Care Inc. is a portable blood analyzer used for quantifying blood gases (pH, PO2, PCO2) and lactate levels in arterial, venous, and capillary whole blood. It provides quick and accurate testing at the point of care or in clinical laboratory settings, helping clinicians diagnose and manage respiratory, metabolic, and acid-base disorders as well as tissue hypoxia and lactic acidosis.
Intended Use
The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings. It is also intended for in vitro quantification of lactate in arterial or venous whole blood.
Technology
The system consists of a handheld i-STAT 1 analyzer and disposable i-STAT CG4+ cartridges containing sensors, fluidic channels, and calibrant pouches. Blood samples are applied to the cartridge, which automates fluid transport and sensor measurement to quantify blood gases and lactate. The analyzer controls timing, heating, and electrochemical measurement to generate results.
Performance
Performance studies demonstrated precision, reproducibility, linearity, traceability, interference testing, altitude studies, method comparison, and matrix equivalence supporting safety and efficacy of pH, PO2, PCO2, and lactate measurements in whole blood. The system showed substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/26/2024
4 months - 2
FDA Approval
5/2/2025
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