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IL New Automated Total Bilirubin Assay Wins FDA Clearance

Instrumentation Laboratory (IL) has received FDA clearance to market the rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns.

The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds from whole blood in the Neonatal Intensive Care Unit (NICU), rather than waiting up to an hour for results from the lab, using traditional chemistry methods.

The American Academy of Pediatrics recommends that a risk-assessment for bilirubin be performed on every newborn to reduce the incidence of adverse events.

The tBili assays performed on the GEM Premier 4000 are not affected by moderate turbidity or hemolysis, ensuring accuracy. Additionally, from a single whole blood sample, a full range of analytes can be measured, including Blood Gas, Electrolytes, Glucose, Lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status.

IL has reported about the FDA clearance of the tBili assay at the Annual Meeting of the American Association for Clinical Chemistry in Anaheim, California. At the meeting, IL has also introduced GEMweb Plus Custom Connectivity, software for automated information management.

IL said that the GEMweb Plus is the software to provide system-wide, bi-directional capabilities from any networked PC of GEM Premier 4000 analyzer. GEMweb Plus provides complete control of all networked analyzers, regardless of location, to enhance quality assurance and regulatory compliance.

Ramon Benet, VP of US sales and worldwide service and marketing at IL, said: “Now, with the addition of the tBili assay to the GEM Premier 4000 analyzer, screening can be performed immediately, with the highest quality results assured. No other analyzer can provide lab-quality tBili results in the NICU.”