Abbott announced that the FDA has given 510(k) clearance for its ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test to aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease.

The ARCHITECT Clinical Chemistry HbA1c test allows physicians to quickly evaluate a patient’s average blood glucose concentration over several months, and proceed with treatment options if necessary. HbA1c levels can aid in the diagnosis of diabetes mellitus, identify patients at risk, and monitor long-term glucose control in patients with diabetes mellitus.

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The HbA1c assay measures the percent HbA1c or the HbA1c concentration (mmol/mol) in human whole blood and hemolysate on the ARCHITECT c8000 System. The test will be available in the coming weeks.

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