FDA Clears Sekisui’s Diabetes Assay

The FDA granted 510(k) clearance for Sekisui Diagnostics’ Sekure Hemoglobin A1C (HbA1c) assay for diagnosing diabetes mellitus.

The assay eliminates manual preparation prior to testing. It is now available on the company’s SK 500 clinical chemistry system.

The HbA1c assay has also been cleared for identification of patients at risk for developing the disease and monitoring long-term blood glucose controls in individuals that have the disease.