510(k) for Genzyme Diagnostics:
This article was originally published in Clinica
Executive Summary
Genzyme Diagnostics has received FDA 510(k) clearance to market its GlyPro assay for monitoring blood glucose levels in diabetic patients. By measuring the level of glycated serum proteins, commonly known as fructosamine, the test presents doctors with a representative measurement of the average blood glucose levels from the previous two to three weeks. This offers a cost-effective way of measuring glucose control over time, said the Cambridge, Massachusetts-based company.