Instrumentation Laboratory (IL), a Werfen company, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Gem Premier Chemstat in vitro diagnostic (IVD) analyzer with intelligent quality management (iQM).
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Part of the GEM Premier family, the new Gem Premier Chemstat system has been developed for quick basic metabolic panel (BMP) testing at the point of care, mainly in hospital emergency departments (ED) and clinical laboratory.
Gem Premier Chemstat system is said to offer laboratory-quality results within 70 seconds from venous or arterial whole blood samples without any preparation, enabling to improve patient management, reduce length of stay and enhance efficiency.
The system, which features a complete BMP panel, provides three new tests such as creatinine, blood urea nitrogen (BUN) and measured tCO2. It also provides tests such as sodium, potassium, ionized calcium, chloride, Glucose, as well as lactate, hematocrit, pH and pCO2.
BMP is a major test used for diagnosing acute conditions, including kidney failure, insulin shock, respiratory distress, and arrhythmias.
Gem Premier Chemstat system incorporates iQM) to provide laboratory-quality results at the point of care. It allows to offer complete picture of quality for each sample in real time and facilitates automated detection, correction and documentation of any action.
GEMweb Plus custom connectivity allows to manage all Gem Premier analyzers in a network, including the Gem Premier Chemstat system, for complete control of instruments, operators and data oversight from any location.
IL worldwide marketing vice president Giovanni Russi said: “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.
“With the flexibility of venous sampling and lab-quality results in 70 seconds, the system will play a key role in prioritizing acutely ill patients, expediting time to treatment, increasing operational efficiencies and enhancing patient care.”
Established in 1959, Instrumentation Laboratory is engaged in the development, manufacturing and distribution of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories.