Phone: 781-894-0800
[email protected]
www.novabiomedical.com
200 Prospect St., Waltham, MA 02454
The only glucose meter FDA cleared for use with critically ill patients, the Nova StatStrip® Glucose Hospital Meter System, is now also FDA cleared for fingerstick capillary testing with critically ill patients. StatStrip Glucose is being shown at the Nova Biomedical booth #1814.
The FDA granted 510(k) clearance to StatStrip for capillary testing with critically ill patients following extensive prospective and retrospective studies performed at the Mayo Clinic in Rochester, MN, and Johns Hopkins Bayview Medical Center in Baltimore, MD. The submission data comprised 16,778 patients ranging from one month to 106 years old, all who were receiving intensive medical intervention/therapy in critical and intensive care settings including burn, cardiac, medical, orthopedic, neurological, and surgical.
StatStrip’s capillary results were equivalent to the arterial and venous plasma results measured on a central laboratory IDMS traceable reference method. The FDA clearance indicates that StatStrip is safe, effective, and reliable for use by CLIA-waived operators with critically ill patients.
Nova is also showing its Stat Profile Prime Plus® critical care blood gas analyzer featuring ZERØ™ Maintenance cartridge technology, simple operation, maximum uptime, and lowcost testing. Prime Plus* is a comprehensive, whole blood critical care analyzer that offers blood gases, electrolytes, metabolites, co-oximetry, and 32 calculated results in a simple, compact device. Prime Plus combines maintenance-free, replaceable cartridge technology for sensors and reagents with patented, new, maintenance-free and non-lysing whole blood co-oximetry technology. Test menu includes pH, PCO2, PO2, Na, K, Cl, iCa, iMg, Glucose, Lactate, Urea, Creatinine, Hct, Hb, SO2%, and Co-Ox.
Prime Plus produces rapid results—a complete test menu panel in about one minute—and offers bidirectional connectivity and a powerful onboard data management system. Calibrator and quality control (QC) cartridges are immediately ready to use and easily replaced in seconds. * FDA Clearance Pending
In addition, Nova will present CE-credited seminars on critical care glucose and lactate testing. All seminars are 30 minutes and offered on multiple days for your convenience. Attend as many as you like and earn CE credits for all.
Seminars:
Using capillary specimens in critically ill patient glucose testing
Point-of-care lactate testing: An essential tool in critical care
Importance of measuring ionized Magnesium (iMg++) in patients with critical care conditions