FDA gives 510(k) approval for the SEKURE HbA1c assay for diabetes.-Sekisui Diagnostics.

Sekisui Diagnostics announces the FDA clearance of their SEKURE HbA1c assay. The assay has been cleared to be used as an aid in the diagnosis of diabetes mellitus, as an aid in identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The SEKURE HbA1c assay is used in clinical laboratories to measure the percent concentration of HbA1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate. It is an enzymatic assay which is NGSP certified and utilizes an onboard pretreatment step on Sekisui Diagnostics SK 500 Clinical Chemistry System, eliminating time-consuming manual preparation prior to testing. With the FDA clearance, the SEKURE HbA1c test is now available on the SK500 in both the US as well as the European Union as it previously obtained a CE mark.