Abbott has received CE Mark for its Architect clinical chemistry Hemoglobin A1c (HbA1c) test, which may assist physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.
The HbA1c test is a blood test that reflects a person’s average blood glucose levels over the past three months.
Abbott Diagnostics Products senior medical director Christian Fischer said that the new Architect clinical chemistry HbA1c test provides physicians with important information that may help patients take critical steps to manage the progression of this very serious disease.
Abbott Diagnostics Products executive vice president Brian Blaser said that when diabetes is not managed properly, it can lead to damage of important systems in the body, including the heart, kidneys, and eyes, and even cause life-threatening complications.
"With the CE Mark of Abbott’s ARCHITECT clinical chemistry HbA1c test, we are pleased to offer this valuable tool to help doctors diagnose diabetes and identify patients at-risk for developing diabetes," Blaser added.
Abbott has recently filed for 510(k) clearance with the US Food and Drug Administration (FDA).