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Instrumentation Laboratory Gets FDA Clearance for Dx Analyzer, Sample Quality Manager

NEW YORK (360Dx) – Instrumentation Laboratory has received 510(k) clearance from the US Food and Drug Administration for the GEM Premier 5000 analyzer with the Intelligent Quality Management 2 quality assurance system for use at the hospital point of care.   

The firm said that the GEM Premier 5000 system provides results in seconds from whole blood treated with heparin, and measures several parameters, including blood gases, electrolytes, metabolites, and a full CO-Oximetry panel. 

Speed of results and variety of parameters enable clinicians to make fast decisions for patient management in acute care settings, while saving costs and personnel time, IL added.  

The intelligent quality management component provides a picture of the quality of each sample continuously and in real-time, and it checks for quality before, during, and after sample analysis.

IL’s Vice President of Worldwide Marketing Giovanni Russi said in a statement that the system overall helps “hospitals improve patient care while enhancing the efficiency of testing and reducing the total cost of care."

Last year, the firm received a CE mark for the GEM Premier 5000, enabling it to market the system in selected European countries. In 2017, it will begin marketing the cleared system in the US.