EKF launches FDA CLIA-waived β-ketone and glucose POC analyzer to U.S. market

EKF launches FDA CLIA-waived β-ketone and glucose POC analyzer to U.S. market

View Supplier Profile Mar 13 2020 EKF Diagnostics, the global in vitro diagnostics company, announces a new addition to its Diabetes Care portfolio in the U.S.. The STAT-Site WB is a dual-use whole blood β-ketone and glucose meter for professional use in the management of diabetes. The new FDA CLIA-waived handheld analyzer reliably and efficiently delivers results within just 5-10 seconds, and can be used in point-of-care (POC) and Certificate of Waiver settings, such as physicians’ offices, clinics and other non-traditional laboratory locations. EKF Diagnostics’ STAT-Site WB β-ketone and glucose whole blood analyzer As a dual analyte measurement system, the STAT-Site WB can quantitatively measure β-ketone (Beta-Hydroxybutyrate or BHB) from both fresh capillary and venous whole blood in 10 seconds. In addition, it delivers quantitative measurements in 5 seconds for glucose in fresh capillary, venous and also neonatal whole blood. Results are reported on its clear LCD screen and up to 400 can be stored in memory; these can be downloaded using a simple mini USB cable. The new system is very simple and intuitive to use as it is reagent free, using test strips to which whole blood is added directly. These are available either individually foil-wrapped or in a vial with a shelf life of six months once opened. For easy handling, the test strips are wide and a strip indication light on the analyzer light guides insertion. Further enhancing its ease-of-use, the STAT-Site WB’s strip identification system, automatically differentiates whether a blood glucose or β-ketone test strip has been inserted and will analyze accordingly via its auto start function. Just 1 µL of whole blood is required for this analysis and the system will detect and alert if insufficient blood is available. Also supporting inexperienced users, an automatic strip ejection function ensures that cross contamination is avoided. Related Stories



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