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First A1c test labeled for diagnosing diabetes allowed for marketing by FDA


On Thursday May 23, 2013 the U.S. Food and Drug Administration (FDA) announced that it will allow marketing of the first HbA1c test labeled for diagnosing diabetes by doctors. The device that was approved is the COBAS INTEGRA 800 Tina-quant HbA1c assay (Tina-quant HbA1cDx assay) which is made by Roche of Basel, Switzerland. The Roche North American headquarters are located in Indianapolis, IN.

Currently HbA1c tests or A1c tests are FDA approved for monitoring a patient’s blood glucose (sugar) control, but not for diagnosing diabetes. A1c tests will measure the percentage of hemoglobin A1c that is bound to glucose. This test will give both the patient and health care professional a average glucose level over a three-month period.

The FDA said over-the-counter HbA1c tests should not be used by patients to diagnose diabetes, and only a qualified healthcare professional should make a diagnosis of diabetes.

If left untreated, diabetes can lead to serious long-term problems such as heart disease, stroke, and damage to kidneys, nerves and eyes. Diabetes is a serious health condition that affects and estimated 25.8 million people in the United States alone, including seven million people who are undiagnosed.

To read more please visit the FDA website.

To purchase a lab accurate over-the-counter A1c test today!