FDA has recently granted premarket notification (510(k)) clearance for the Gem Premier ChemStat in vitro diagnostic analyzer with intelligent quality management from Instrumentation Laboratory, Bedford, Mass.

A new and complementary member of the company’s Gem Premier family of analyzers, the Gem Premier ChemStat system is designed to perform rapid basic metabolic panel testing at the point of care, primarily in hospital emergency departments. The system provides laboratory-quality results from venous or arterial whole blood samples in less than 70 seconds, with no preparation required, helping to improve patient management, reduce length of stay, and enhance efficiency.

Featuring a complete basic metabolic panel, the system offers three new tests—blood urea nitrogen (BUN), creatinine, and measured tCO2—in addition to chloride, glucose, hematocrit, ionized calcium, lactate, pCO2, pH, potassium, and sodium. The basic metabolic panel is one of the most widely ordered tests for diagnosing acute conditions, such as arrhythmias, insulin shock, kidney failure, and respiratory distress.

“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,” says Giovanni Russi, a vice president at Instrumentation Laboratory. “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 incorporates an intelligent quality management system that provides a complete picture of quality for each sample—continuously and in real-time. To ensure the quality of every test result, the system also provides automated detection, correction, and documentation of any action it performs, supporting immediate patient management decisions.

Additionally, GemWeb Plus custom connectivity enables management of all Gem Premier analyzers in a network, including the Gem Premier ChemStat system, for complete oversight of instruments, operators, and data from any location. Gem Premier systems, combined with GemWeb Plus 500 connectivity, deliver a complete solution for improved patient care and efficiency.

Gem Premier ChemStat analyzers are exceptionally easy to use. The all-in-one, multiuse GemPak cartridge automates the most labor- and skill-intensive processes. The cartridge is replaced every 3 weeks, with no additional handling required. No maintenance is needed, and all testing components are self-contained, limiting biohazard and infection risk for operators and patients.

Over the coming months, the company expects to receive additional regulatory approvals for markets around the world, and will then announce further commercialization plans for the Gem Premier ChemStat system.

For further information, visit Instrumentation Laboratory.