FDA Approves New Diabetes Diagnostic Tool

April 14, 2014
Rachel Lutz

A tool for diagnosing and monitoring diabetes has received 510(k) clearance from the US Food and Drug Administration.

A tool for diagnosing and monitoring diabetes has received 510(k) clearance from the US Food and Drug Administration (FDA), Abbott announced in a press release.

The ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test measures the hemoglobin concentration in the blood, which can aid a diabetes diagnosis and also help identify people at risk for the disease, according to the release.

“At times, diabetes can be difficult to diagnose because the symptoms can be subtle or go unnoticed,” said Beth McQuiston, MD, medical director of Abbott Diagnostics. “The new HbA1c test provides physicians the ability to quickly assess a person’s average blood glucose concentration over several months, and if needed, provide them with a treatment pathway to help optimize their health.”

Brian Blaser, executive vice president of Diagnostics Products, added “the progression of diabetes may be prevented or delayed with effective care, (so) Abbott's ARCHITECT clinical chemistry HbA1c test will empower physicians to take timely, appropriate actions in identifying and helping people manage this disease.”

The HbA1c test should not be used to diagnose patients with abnormal red cell turnover, such as pregnancy, recent blood loss or transfusion, and some types of anemia, the FDA warned.