GEN -- Sphere Medical’s IVD-GE02 blood analyzer has achieved FDA 510(k) clearance. The firm claims the device is the first multiple-use, microchip-based blood analyzer to attain 510(k) approval. Based on Sphere’s silicon microchip technology that allows the simultaneous analysis of a range of analytes, the IVD-GE02 platform is designed to measure glucose, pH, carbon dioxide, oxygen, and potassium ions in blood samples, with a performance that matches that of a standard clinical laboratory analysis. Sphere says it working to add new analytes to the panel, including hematocrit, lactate, sodium, and ionized calcium.
