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FDA Clears Diazyme Smart HbA1c Assay For Diabetes Monitoring

Diazyme Laboratories has received FDA 510(k) clearance to market Smart HbA1c Assay on its new Smart Point of Care System for diabetes monitoring. The Smart HbA1c Assay offers rapid testing capabilities and is based on Diazyme's Direct Enzymatic HbA1c assay technology.

Diazyme said that the assay can be run from a simple finger stick blood sample obtained in a physician’s office and delivers accurate and reliable results in minutes. Unlike other point of care systems for HbA1c, the Diazyme Smart HbA1c Assay has been shown to have no interference from common hemoglobin variants including Hb E, Hb C, Hb S and Hb D traits.

The assay offers freedom from interference in HbA1c testing, which is of special importance today as the HbA1c test is now considered the key test for diagnosis and screening of diabetic disease.

Chong Yuan, managing director of Diazyme Laboratories, said: “Diazyme’s new Smart HbA1c Assay provides a convenient and cost effective test method which will benefit laboratories, physicians and the patients they care for. In addition to HbA1c, the Smart Point of Care System offers the capability to run tests for monitoring renal function as well as cardiac risk assessment.

“Additional assays in development for the Smart Point of Care System include Cystatin C, which has been shown to be a more reliable marker than creatinine for early detection of acute and chronic kidney disease, and Enzymatic Homocysteine and high sensitivity hsCRP, both of which are important biomarkers for cardiac and stroke risk assessment.”

California-based Diazyme is a division of General Atomics and uses its enzyme platform technologies to develop low cost and uniform diagnostic products for clinical and research uses. Products include diagnostic blood tests for liver disease, cardiac markers, diabetes, renal disease and electrolytes.