Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Mar 22, 2011

Sphere Medical Achieves 510(k) Clearance for Multianalyte Blood Analyzer

  • 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.”

     

     



Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »