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FDA Clears Sekisui Dx's HbA1c Assay

NEW YORK (360Dx) – Sekisui Diagnostics said today that the US Food and Drug Administration has cleared the company's Sekure HbA1c assay as an aid in the diagnosis of diabetes mellitus.

It also has been cleared to aid in identifying patients at risk of developing diabetes mellitus and for the monitoring of long-term blood glucose control of patients with the condition.

Seksui's test is used in clinical labs to measure the percent concentration of HbA1c or the HbA1c fraction mmol/mol in human venous whole-blood and hemolysate. The enzymatic assay uses an onboard pretreatment step on Sekisui's SK 500 Clinical Chemistry System, and is now available in the US and the European Union where it was previously CE marked.

Sekisui noted that more than 30 million people in the US and 425 million globally have diabetes. In the US 1 in 4 people with the condition are unaware they have it, the firm added.