Abbott announces FDA clearance for new ARCHITECT Clinical Chemistry HbA1c test

April 16, 2014

Abbott has announced that its new ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The ARCHITECT HbA1c assay is used in clinical laboratories for the quantitative in vitro measurement of the percent hemoglobin A1c (% HbA1c) or the hemoglobin A1c concentration (mmol/mol) in human whole blood and hemolysate on the ARCHITECT c8000 System.

Hemoglobin A1c measurements are used as an aid in the diagnosis of diabetes mellitus, to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. Hemoglobin A1c should not be used for the diagnosis of diabetes in patients with abnormal red cell turnover, such as pregnant women or patients who have experienced recent blood loss or transfusion or have some types of anemia.

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

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

The ARCHITECT clinical chemistry HbA1c test is now available in several countries throughout Europe, Asia, Latin America, Canada, and Africa, pending country registration. The test will be available in the U.S. in the coming weeks. Read product information for the ACHITECT family of products.

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