FDA Clears Abbott's HbA1c Test For Diabetes

Abbott announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test. The new test can help physicians diagnose and monitor diabetes as well as identify people at risk for the disease.

The ARCHITECT HbA1c assay is used to quantitatively measure the percent hemoglobin A1c or the hemoglobin A1c concentration (mmol/mol) in human whole blood and hemolysate on the ARCHITECT c8000 System. HbA1c measurements are used as an aid in the diagnosis of diabetes mellitus. It is also used to identify patients who may be at risk for developing the disease as well as the monitoring of long-term blood glucose control in individuals with diabetes mellitus. Abbott’s ARCHITECT HbA1c test is fully automated and provides fast and accurate results.

Beth McQuiston, registered dietitian and medical director of Diagnostics at Abbott, said, “At times, diabetes can be difficult to diagnose because the symptoms can be subtle or go unnoticed. 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.”

Over 25 million patients in the U.S. have diabetes, with several million remaining undiagnosed. Abbott believes that people with diabetes who can understand and manage their condition can delay or even prevent health problems, which help lead to longer lives.

Brian Blaser, EVP of Diagnostics Products at Abbott, said, “The progression of diabetes may be prevented or delayed with effective care. Abbott's ARCHITECT clinical chemistry HbA1c test will empower physicians to take timely, appropriate actions in identifying and helping people manage this disease.”

The new ARCHITECT clinical chemistry HbA1c test is available in several countries across Europe, Asia, Latin America, Africa, and Canada pending country registration.