Stat Profile Prime Plus Analyzer Receives FDA Clearance for Point-of-Care Use: Reports Nova Biomedical

Nova Biomedical announced the U.S. Food and Drug Administration (FDA) has cleared its Stat Profile Prime Plus critical care blood gas analyzer for point-of-care (POC) use. This clearance allows POC personnel to perform bedside critical care testing with lab-quality results in as little as one minute.

Prime Plus features maintenance-free sensor technology to provide 19 essential critical care tests including blood gases, electrolytes, metabolites, hematology, and co-oximetry, providing clinicians with a rapid, detailed diagnostic profile, including a comprehensive metabolic panel.

The Prime Plus MicroSensor Card™ provides a critical care panel which includes pH, PCO2, PO2, SO2%, Na, K, Cl, iCa, iMg, glucose, lactate, urea, creatinine, Hct, Hb, O2Hb, COHb, MetHb, and HHb and requires a small 60μl minimum sample volume. Prime Plus features patented, non-lysing whole blood co-oximetry technology, which eliminates corrosive lysing reagents and mechanical complexity while improving instrument reliability and reducing costs.

Prime Plus incorporates Nova’s innovative, maintenance-free sensor technology with individual MicroSensor Cards, calibrator cartridges, and quality control cartridges. This design eliminates sensor and co-oximeter maintenance, improves analyzer uptime, and reduces testing costs.

A unique safety sample port allows for easy docking and hands-free sampling, and the Clot Block™ sample flow path protects sensors from blood clot blockages and related downtime.

Prime Plus provides real-time supplemental quality monitoring with automated QC that verifies analyzer accuracy and precision. The on-board assayed liquid controls meet or exceed all current regulatory guidelines and do not require the development of an Individualized Quality Control Plan (IQCP). Supplemental quality monitoring electronically tracks and verifies analytical performance between QC intervals and for each analysis and calibration.

 

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