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  1. In Vitro Diagnostics

Letter to Manufacturers With HbA1c Assays Listed With the FDA

OIVD has sent the following letter to manufacturers with HbA1c assays listed with the FDA.

[Manufacturer address]

Dear [Contact name]:

Recently, the American Diabetes Association (ADA) published updated recommendations for medical practice standards in diabetes1. According to these new recommendations, Hemoglobin A1c (HbA1c) values ≥ 6.5%2 may now be used to diagnose diabetes. This recommendation is supported by data collected as part of the Diabetes Control and Complications Trial (DCCT) as well as numerous other studies performed over the past two decades. Other clinical organizations, such as the American Association of Clinical Endocrinologists and the Endocrine Society have since expressed qualified support of this new recommendation.

As a result of the recent change in practice guidelines, we have received a number of inquiries from manufacturers on whether their cleared tests may be promoted for use in diagnosing diabetes. Currently, all HbA1c tests that have been cleared by the Food and Drug Administration (FDA) have been indicated to monitor long-term glucose control in individuals with diabetes mellitus. Devices cleared with this type of indication would need a new FDA clearance to allow promotion of the device for the diagnosis of diabetes. To date, no HbA1c tests have been cleared with a diagnosis claim, but we believe that certain devices may be able to obtain such a claim with data demonstrating that they are accurate and reliable enough for this purpose.

Your company has been identified as having listed HbA1c assay(s) with the FDA [product code LCP or NGB]. If you are interested in pursuing this new claim for your HbA1c test and have met the current NGSP criteria for certification, we encourage you to contact us, via a Pre-IDE submission, to discuss the additional data that may be necessary to obtain clearance for this use. We look forward to working with all interested test manufacturers on this issue to ensure that HbA1c tests used to diagnose patients are safe and effective for that purpose.

Sincerely yours,


Courtney C. Harper, Ph.D.
Division of Chemistry and Toxicology Devices
Center for Devices and Radiological Health

1 American Diabetes Association, Standards of Medical Care in Diabetes – 2101, Diabetes Care, Volume 33, Supplement 1, January 2010.

2 ADA notes that the test should be performed in a laboratory using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized to the DCCT assay.

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