FDA allows marketing for HbA1c assay to diagnose diabetes

  • May 23, 2013

The FDA has announced they will allow the marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay for the diagnosis of diabetes by health care professionals, according to a press release.

Investigators analyzed 141 blood samples and found a difference of <6% in accuracy between the Tina-quant HbA1cDx assay (Roche) and results from standard reference for HbA1c analysis, according to the release.

Full Story »

Personalize your page!

Register for Healio to get content tailored to your specialty and areas of interest. It’s FREE and only takes one minute. Register now!

  • Healio Minute, May 24, 2013
  • Healio Minute logo
  • CVD drug, EHRs, PICUs
  • Cancer drug shows new side, EHRs tip the balance and PICUs found risky in winter.
More »
More »
More »
More »
Endocrine Today