Abbott announces CE Mark for test to aid with diagnosis and monitoring of diabetes

May 16, 2013

Abbott has announced CE Marking for the ARCHITECT clinical chemistry Hemoglobin A1c (HbA1c) test. In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of type 2 diabetes and identification of patients at risk for developing diabetes if the assay meets specific performance criteria, such as certification and standardization processes outlined by the National Glycohemoglobin Standardization Program and the International Federation of Clinical Chemistry.

“The new ARCHITECT clinical chemistry Hemoglobin A1c test provides physicians with important information that may help patients take critical steps to manage the progression of this very serious disease,” says Christian Fischer, senior medical director, Diagnostics Products, Abbott.

The ARCHITECT HbA1c assay is used in clinical laboratories for the quantitative in vitro measurement of the percent hemoglobin A1c or HbA1c fraction in human whole blood and hemolysate on the ARCHITECT c8000 and c4000 systems. The ARCHITECT clinical chemistry HbA1c test is available in several countries throughout Europe, Asia, Latin America, Canada, and Africa, pending country registration. Abbott recently filed for 510(k) clearance with the U.S. Food and Drug Administration. Learn more about the ARCHITECT systems.