Diazyme HbA1c Point of Care Assay Receives FDA Clearance

Diazyme Laboratories (San Diego, CA) has received FDA clearance for its SMART HbA1c Assay on the SMART Point of Care System for diabetes monitoring. HbA1c or glycated hemoglobin is, of course, a measure of long-time blood glucose control, with its level proportional to average blood glucose concentration over the previous one to three months. The system allows for fast in-office determination of the HbA1c level from a finger stick blood sample. One of the distinguishing features of this test compared to the rest of the market is that it is insensitive to most hemoglobin variants, including Hb E, Hb C, Hb S and Hb D. It uses the fructosyl valine oxidase enzyme and an optical detector to measure the HbA1c level without the need for a separate total hemoglobin measurement. Other tests in development for the SMART system include cystatin C, enzymatic homocysteine and high sensitivity hsCRP.
Press release: Diazyme Receives FDA 510(k) Clearance to Market SMART HbA1c Assay on Its SMART Point of Care System for Diabetes Monitoring…
Product page: Direct HbA1c Point of Care…