IVD-GE02 instrument is designed to simultaneously measure blood glucose, pH, carbon dioxide, oxygen, and potassium ions.


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.”

 

 








This site uses Akismet to reduce spam. Learn how your comment data is processed.