The Food and Drug Administration’s (FDA) approval concerns the cobas c513 analyser and the HbA1c Gen. 3 assay, announced a statement. HbA1c is a glycohaemoglobin, or hemoglobin, that is connected to glucose. Analyses measure the proportion of HbA1c in the hemoglobin to determine the blood sugar value.
Roche developed the analyser to increase the number of tests possible. With cobas c513, the results of 400 patients can be analysed every hour – twice as many as the device’s predecessor, which is now to be replaced by cobas c513.
Every year around 1.4 million Americans are diagnosed with diabetes, revealed Roche Diagnostics chief medical officer, Alan Wright, in the statement. As a result, there is increased demand among healthcare providers for efficient methods of analysis. The newly approved products will facilitate reliable, efficient and high-quality results, according to Wright.