FDA Clears New Nova Critical Care Analyzer, Stat Profile Prime Plus

FDA Clears New Nova Critical Care Analyzer, Stat Profile Prime Plus
New technologies that advance and simplify testing

Nova Biomedical is pleased to announce that a new addition to the Stat Profile line of blood gas critical care analyzers, Stat Profile Prime Plus, has gained FDA clearance. Prime Plus features maintenance-free sensor technology to provide 20 essential critical care tests including blood gases, electrolytes, metabolites, hematology, and co-oximetry. Prime Plus also provides new and patented, non-lysing whole blood co-oximetry technology, along with automated quality control (QC), powerful data management, bidirectional connectivity, and extensive cybersecurity protection.

Prime Plus delivers a comprehensive critical care panel including pH, PCO2, PO2, SO2%, Na, K, Cl, iCa, iMg, glucose, lactate, urea, creatinine, Hct, Hb, O2Hb, COHb, MetHb, and HHb. This provides clinicians the most detailed diagnostic profile including a comprehensive metabolic panel with test results available in as little as one minute. 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 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 for the compact and easy-to-use Prime Plus.

The MicroSensor Card™ supports 20 critical care assays including co-oximetry and unique critical care assays for urea, creatinine, and ionized magnesium with a small 60μl minimum sample volume. Prime Plus offers a complete co-oximetry panel without chemically or mechanically lysing the blood, which eliminates corrosive lysing reagents and mechanical complexity while improving instrument reliability and reducing costs.

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 of the current regulatory guideline 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.

Prime Plus features a powerful data management solution which supports bidirectional connectivity, remote analyzer review and control of connected Prime Plus analyzers, and the most comprehensive cybersecurity features to protect patient health information and prevent viruses.

“We at Nova Biomedical are thrilled to introduce the U.S. market and FDA cleared countries to the next evolution of the Stat Profile Prime platform with its flagship analyzer, the Prime Plus,” said Brad Bullen, BS, RCP, global sales product line manager at Nova. “Prime Plus introduces innovative technology that expands critical care testing with unique assays and eliminates sensor and co-oximeter maintenance, all of which improves uptime and reliability while reducing costs. Prime Plus represents the latest in critical care testing technology and further demonstrates Nova’s leadership and history of innovation.”

*FDA K180340