Beckman Coulter Receives FDA Clearance on Next Generation Hemoglobin A1c Test

Beckman Coulter has received U.S. Food and Drug Administration (FDA) clearance on a new Hemoglobin A1c assay (HbA1c-) with improved performance for standard use on the company’s UniCel DxC Systems.


The HbA1c- reagent has been designed and developed to improve accuracy and precision in order to continue to meet the latest accuracy grading from the College of American Pathologists (CAP) and the recommendations of the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry (IFCC). HbA1c- is standardized and holds a certificate from the NGSP.

Features of the new HbA1c- assay include:

• Ready-to-use liquid reagents for A1c and Total Hemoglobin
• 5-level calibrator set
• 30-day on-board reagent stability
• 7-day calibration stability
• No cross reactivity with HbA1a, HbA1b, acetylated hemoglobin, carbamylated hemoglobin and glycated albumin
• No significant interference from hemoglobin variants HbS, HbC, HbD, HbE, and HbF

“In order to meet future requirements, Beckman Coulter has developed the next generation HbA1c assay to ensure laboratories continue to meet the latest recommendations of NGSP, CAP and IFCC,” said Jack Zakowski, Ph.D., FACB, director of Beckman Coulter Diagnostics Scientific Affairs. “Ultimately, the standardization and new assay will allow physicians to maintain diabetic patients under better glycemic control and therefore reduce complications of the disease.”

Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus. Determination of hemoglobin A1c provides the average level of blood glucose over the previous three months and is an important tool for monitoring the efficiency of dietary control and therapy during treatment for diabetes.

HbA1c-, when used in conjunction with Beckman Coulter’s UniCel DxC System and Synchron/AU Hemolyzing reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.

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