Instrumentation Laboratory obtains FDA 510(k) clearance for GEM Premier 5000
Instrumentation Laboratory (IL) has received US Food and Drug Administration (FDA) 510(k) clearance for GEM Premier 5000, an in-vitro diagnostic (IVD) analyser combined with Intelligent Quality Management 2 (iQM2).
The new testing system is available as part of IL's critical care line, which includes GEM Premier 4000, GEM Premier 3500 with Intelligent Quality Management (iQM), and GEMweb Plus Custom Connectivity.
IL's worldwide marketing vice-president Giovanni Russi said: "IL has a long history of innovation in the IVD market and the new GEM Premier 5000 with iQM2 is a shining addition.
"It is a true intelligent analyser because iQM2, the brain of the system, automatically handles quality control and overall quality management in real-time, with no operator intervention required.
"It is a perfect solution to help hospitals improve patient care, while enhancing the efficiency of testing and reducing the total cost of care."
The system is capable of measuring blood gases, electrolytes, metabolites, and a full CO-Oximetry panel, from heparinised whole-blood samples.
Designed for use at the hospital point-of-care, this system provides accurate results in seconds, allowing clinicians to make patient management decisions in acute care settings more quickly.
The iQM2 helps ensure the quality of every test result for GEM Premier 5000 system by conducting a continuous cycle of five quality checks before and after every sample. It also employs IntraSpect technology to check the samples during analysis too.
In addition, iQM2 provides immediate correction and automatic documentation of any action it performs to ensure the quality of test results.
The new GEMweb Plus 500 Custom Connectivity is a data manager, which connects all GEM Premier analysers in a system for complete control of instruments, operators, and data oversight from any location.