Instrumentation Laboratory Received US FDA Clearance for NEW GEM Premier 5000 Critical Care Testing System
Intelligent Analyzer, a Breakthrough in Quality Management and Simplicity
Bedford, MA - December 19, 2016
Instrumentation Laboratory (IL) today announced the 510(k) clearance of their latest innovation, the GEM Premier 5000 in vitro diagnostic (IVD) analyzer with Intelligent Quality Management 2 (iQM®2) by the US Food and Drug Administration (FDA). Designed for use at the hospital point-of-care, this system represents a true breakthrough in quality management and simplicity. Measuring critical parameters, including blood gases, electrolytes, metabolites, and a full CO-Oximetry panel, from heparinized whole-blood samples, the GEM Premier 5000 system provides accurate results in seconds. This allows clinicians to make patient management decisions in acute care settings faster, while saving costs and personnel time, essential in today’s healthcare environment.
iQM2 provides a complete picture of quality for each sample – continuously and in real-time – ensuring the quality of every test result. With a continuous cycle of five quality checks, not only does iQM2 perform quality checks before and after every sample, but now with IntraSpect technology, samples are checked during analysis too. Plus, iQM2 provides immediate correction and automatic documentation of any action it performs to ensure the quality of test results. No competitive system offers this assurance of sample quality and compliance.
“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 Analyzer” because iQM2, the “brain” of the system, automatically handles the quality control and overall quality management in real-time, with no operator intervention required,” said Giovanni Russi, VP of Worldwide Marketing at IL. “It is a perfect solution to help hospitals improve patient care while enhancing the efficiency of testing and reducing the total cost of care.”
Additionally, new GEMweb® Plus 500 Custom Connectivity will now be introduced on GEM Premier 5000 systems. This data manager connects all GEM Premier analyzers in a system, including GEM Premier 4000, for complete control of instruments, operators and data oversight from any location. The GEM Premier 5000 system, combined with GEMweb Plus 500 delivers a complete solution for improved patient care and efficiency.
Not only assuring quality, GEM Premier 5000 systems are also exceptionally simple to use. The all-in-one, multi-use GEM PAK cartridge automates the most labor- and skill-intensive processes. No maintenance is required and all testing components are self-contained, limiting biohazard and infection risk for operators and patients. The PAK is simply replaced monthly and no additional handling is required. Thirty different PAK menu and volume configurations are available, providing flexibility for each testing location.
Last year, IL received European CE IVD Mark for the GEM Premier 5000 system, allowing the Company to initiate commercialization in selected European countries. As the product continues to be introduced in markets around the world, commercialization in the US will commence in 2017.
Other instrument models in the GEM Premier Family include the GEM Premier 4000, GEM Premier 3500 and GEM Premier 3000 systems. The GEM Premier 3000 is available only in select territories and is not available in North America.