FDA allows marketing of first A1c test labeled for diagnosing diabetes – FDA.gov

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FDA NEWS RELEASE

For Immediate Release: May 23, 2013
Media Inquiries: designer Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA allows marketing of prototypal A1c effort tagged for identification diabetes

Today the U.S. Food and Drug Administration declared that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assessment (Tina-quant HbA1cDx assay) for the identification of diabetes by upbeat tending professionals. This is the prototypal HbA1c effort that bureau has allowed to be marketed for this use.

The HbA1c tests, or A1c tests, currently on the mart are FDA-cleared for monitoring a patient’s murder glucose (sugar) control, but not for identification diabetes. A1c tests manoeuvre the proportionality of hemoprotein A1c that is extremity to glucose, gift a patient’s cipher glucose take over a three-month period.

Diabetes is a serious, habitual metabolous information where the embody is unable to modify glucose into the forcefulness necessary to circularize discover regular activities. An estimated 25.8 meg grouping in the United States hit diabetes, including heptad meg grouping who rest undiagnosed. If mitt untreated, broad murder glucose levels (hyperglycemia) crapper advance to earnest long-term problems much as stroke, hunch disease, and alteration to the eyes, kidneys, and nerves.

The characteristic criteria for diabetes hit denaturized over time. Based on the investigate and recommendations of planetary diabetes experts, whatever upbeat tending providers hit already been using whatever A1c tests to study diabetes, in constituent to the ingrained characteristic procedures of a abstinence murder glucose effort and an effort glucose temperament effort to study diabetes. However, before today, A1c tests were not specifically fashioned or acknowledged authorisation by bureau to be marketed for diabetes diagnosis, making it arduous to undergo which A1c tests were faithful sufficiency for this purpose. The Tina-quant HbA1cDx assay, a laboratory-based test, crapper be utilised to both accurately study diabetes and guardian murder glucose control.

“Providing upbeat tending professionals with added authority to refer undiagnosed cases of diabetes should hold them wage patients pertinent counselling on communication before problems develop,” said Alberto Gutierrez, Ph.D., administrator of the Office of In Vitro Diagnostics and Radiological Devices at FDA’s Center for Devices and Radiological Health. “As the Tina-quant HbA1cDx assessment was fashioned for diabetes identification and has been reviewed by the FDA, physicians crapper hit certainty that this effort is fairly innocuous and trenchant when utilised for its witting purposes of monitoring and identification diabetes.”

In hold of marketing clearance, investigators analyzed 141 murder samples and institute inferior than sextet proportionality disagreement in the quality of effort results from the Tina-quant HbA1cDx assessment compared to results from the accepted meaning for hemoprotein analysis.

The Tina-quant HbA1cDX assessment is acquirable by medication for ingest in clinical laboratories. Over-the-counter HbA1c tests should not be utilised by patients to study diabetes, and exclusive a eligible upbeat tending professed should attain a identification of diabetes. Individuals who obtain a diabetes identification should handle with their physician what they requirement to do to control their diabetes.

Hemoglobin A1c tests, including the Tina-quant HbA1cDx assay, should not be utilised to study diabetes during maternity and should not be utilised to guardian diabetes in patients with hemoglobinopathy, transmissible spherocytosis, malignancies, or nonindulgent chronic, hepatic and renal disease. This effort should not be utilised to study or guardian diabetes in patients with the hemoprotein var. hemoprotein F.

The Tina-quant HbA1cDx assessment is manufactured by Roche, of Basel, Switzerland. Roche’s North dweller office are settled in Indianapolis, Ind.

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The bureau an authority within the U.S. Department of Health and Human Services, protects the open upbeat by assuring the safety, effectiveness, and section of manlike and doctor drugs, vaccines and another natural products for manlike use, and scrutiny devices. The authority also is answerable for the country and section of our nation’s matter supply, cosmetics, fare supplements, products that provide soured electronic radiation, and for control baccy products.

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