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.
510(k) clearance for the IVD-GE02 instrument represents a “testament to our technology and Sphere Medical itself,” claims Stuart Hendry, Ph.D., CEO. “The challenges to attaining 510(k) clearance for a product such as the IVD-GE02, which combines proprietary microchips, chemistry, software, hardware and novel manufacturing technologies that all have to perform to recognized standards, are very rigorous indeed.”