Abbott has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Architect clinical chemistry Hemoglobin A1c (HbA1c) assay that can help physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.
The company has designed the Architect HbA1c assay for use in clinical laboratories for the quantitative determination of 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.
Abbott claims that the Architect HbA1c test gives fast and accurate results.
Abbott Diagnostics medical director and registered dietitian Dr Beth McQuiston noted that 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," Dr McQuiston added.
Currently, the Architect clinical chemistry HbA1c test is available in several countries throughout Europe, Asia, Latin America, Canada and Africa, pending country registration. This test will be available in the US in the coming weeks.