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US FDA gives marketing clearance to Roche’s HbA1cDx assay test for diabetes diagnosis

The US Food and Drug Administration (FDA) has given its approval for the marketing of Roche's Cobas Integra 800 Tina-quant HbA1cDx assay for the diagnosis of diabetes.

Presently available in the market, the HbA1c tests, or A1c tests are approved by the FDA for measuring the blood glucose (sugar) control, reports However, these are not meant for diagnosing diabetes.

Monitoring the percentage of haemoglobin A1c bound to glucose, A1c tests offer the average glucose level of a patient over a period of three months.

A major health concern, diabetes has affected a population of 25.8 million in the US. If the disease is not treated in time, high blood glucose levels (hyperglycaemia) can cause problems such as heart disease, and damage to the kidneys, eyes and nerves.

FDA gave clearance for the marketing of the tool following the analysis of 141 blood samples, in which investigators found less than 6% difference in the level of accuracy between the tests of Tina-quant HbA1cDx assay and the standard practice for haemoglobin analysis.