NEW YORK (360Dx) – Instrumentation Laboratory (IL) today announced that the US Food and Drug Administration has granted 510(k) clearance for its Gem Premier ChemStat in vitro diagnostic analyzer incorporating its Intelligent Quality Management module.
The system is designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital emergency departments and clinical laboratories, IL said.
BMP is among the most widely ordered tests for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress, and arrhythmias.
IL said that its system provides laboratory-quality results in less than 70 seconds from venous or arterial whole blood samples with no preparation. The system consists of tests for creatinine, blood urea nitrogen, measured total carbon dioxide, sodium, potassium, ionized calcium, chloride, glucose, lactate, hematocrit, pH, and the partial pressure of carbon dioxide.
"The addition of the GEM Premier ChemStat system to our acute care diagnostics instrument portfolio allows us to offer a more complete menu and extends our reach into the emergency department and other clinical settings," Giovanni Russi, vice president of worldwide marketing at IL, said in a statement.
He said that the system will play a key role in prioritizing acutely ill patients, expediting time to treatment, increasing operational efficiencies, and enhancing patient care.
To assure laboratory-quality results at the point of care and supporting immediate patient management decisions, the system provides a complete picture of the quality of each sample, continuously and in real-time, and it provides automated detection, correction, and documentation of the actions it performs, IL said.
The firm said that it will announce commercialization plans for its cleared system as it continues to receive regulatory approvals in markets around the world in the coming months.