Instrumentation Laboratory (IL) announced the 510(k) clearance of their latest innovation, the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM®) by the US Food and Drug Administration (FDA). A new and complementary member of the GEM® Premier™ Family, the GEM Premier ChemSTAT system is designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital Emergency Departments (ED) and the Clinical Laboratory. The system provides laboratory-quality results in less than 70 seconds, from venous or arterial whole blood samples with no preparation required, helping to improve patient management, reduce
Featuring a complete BMP panel, the system offers three new tests—Creatinine, Blood Urea Nitrogen (BUN) and measured tCO2—in addition to Sodium, Potassium, Ionized Calcium, Chloride, Glucose, as well as Lactate, Hematocrit, pH and pCO2. BMP is one of the most widely ordered tests for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress, and arrhythmias.
“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,” said Giovanni Russi, VP of Worldwide Marketing at IL. “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.”
To assure laboratory-quality results at the point of care, the GEM Premier ChemSTAT system integrates Intelligent Quality Management (iQM), provides a complete picture of quality for each sample—continuously and in real-time—and automated detection, correction and documentation of any action it performs, to ensure the quality of every test result and supporting immediate patient management decisions. No competitive system offers this assurance of sample quality and compliance.
Additionally, GEMweb® Plus Custom Connectivity enables management of 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. GEM Premier systems, combined with GEMweb Plus 500 connectivity, deliver a complete solution for improved patient care and efficiency.
Like all GEM Premier systems, GEM Premier ChemSTAT analyzers are also exceptionally easy to use. The all-in-one, multi-use GEM PAK cartridge automates the most labor- and skill-intensive processes. No maintenance is needed and all testing components are self-contained, limiting biohazard and infection risk for operators and patients. The PAK is simply replaced every three weeks with no additional handling required.
As the Company continues to receive regulatory approvals in markets around the world in the coming months, commercialization plans for the GEM Premier ChemSTAT system will be announced.