Instrumentation Laboratory (IL) has received FDA 510(k) clearance for the GEM Premier 5000 in vitro diagnostic (IVD) analyzer with Intelligent Quality Management 2 (iQM2), according to the company.
The device is designed for use at the hospital point-of-care and represents a breakthrough in quality management and simplicity, the company said in a press announcement.
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.”
More information is available at the IL website.