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April 16, 2014

Abbott wins FDA clearance for ARCHITECT clinical chemistry haemoglobin A1c test

Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new ARCHITECT clinical chemistry haemoglobin A1c (HbA1c) test, designed to aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.

Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new ARCHITECT clinical chemistry haemoglobin A1c (HbA1c) test, designed to aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.

The fully automated Abbott ARCHITECT HbA1c assay is used in clinical laboratories for the quantitative determination of percent haemoglobin A1c (% HbA1c) or the haemoglobin A1c concentration (mmol/mol) in human whole blood and haemolysate on the ARCHITECT c8000 system.

Percent HbA1c measurements are used in the clinical management of diabetes to assess long-term diabetic control in individuals with diabetes mellitus.

"Abbott’s ARCHITECT clinical chemistry HbA1c test will empower physicians to take timely, appropriate actions in identifying and helping people manage this disease."

According to the company, more than 25 million Americans are living with diabetes and several million remain undiagnosed.

If current trends persist, by 2050 one in every three US adults could have diabetes. Because of this potential rise, laboratories are expected to witness a boost in physician requests for HbA1c tests.

The ARCHITECT HbA1c test provides quick, accurate results, helping laboratories manage this anticipated increase in demand for testing.

Abbott Diagnostics medical director and registered dietitian Dr Beth McQuiston 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," Dr McQuiston said.

The ARCHITECT clinical chemistry HbA1c test is currently available in several countries across Europe, Asia, Latin America, Canada and Africa, pending country registration. The test would be available in the US in the coming weeks.

Abbott Diagnostics Products executive vice-president Brian Blaser 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," Blaser said.

According to the company, haemoglobin A1c should not be used for the diagnosis of diabetes in patients with abnormal red cell turnover, such as pregnancy, recent blood loss or transfusion, or some types of anaemia.

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