April 22, 2020—Abbott’s i-Stat CG4+ and Chem8+ cartridges have received FDA clearance. The i-Stat CG4+ cartridge with the i-Stat 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point-of-care or clinical laboratory settings. With i-Stat CG4+, clinicians may assess the respiratory status of the patient or determine the presence of hyperlactatemia to inform the risk stratification of patients diagnosed with sepsis.
The i-Stat Chem8+ provides chemistries, electrolytes, and hematocrit and hemoglobin levels in about two minutes and can be used for a range of patients in the emergency department, critical care, and oncology, among other clinical settings. The cartridge is cleared for use with venous and arterial whole blood samples in nonwaived settings.