Supplier News Breaks Archives
Bayer Diabetes A1C devices meet tighter criteria
July 23rd, 2010
TARRYTOWN, N.Y. – Bayer Diabetes Care's A1CNow+ and A1CNow SELFCHECK diabetes testing devices have been certified to meet tighter performance guidelines instituted by the National Glycohemoglobin Standardization Program (NGSP).
Bayer this week said it submits for annual NGSP certification each June, and it has now successfully completed certification under the stricter criteria. The company has received a new NGSP certificate valid from July 1, 2010, to July 1, 2011.
As of Jan. 1, the new performance certification standards applicable to devices that measure A1C, or glycated hemoglobin, as set by the NGSP changed to +/-0.75% A1C, 95% CI, 4-10.0% A1C range.
The criteria for last year's NGSP certification was +/-0.85% A1C, 95% CI, 4-12.0% A1C range, according to Bayer.
The purpose of the NGSP is to standardize glycated hemoglobin test results. Standardization allows A1C results to be comparable to those reported in the Diabetes Control and Complications Trial, where relationships to mean blood glucose and risk for vascular complications have been established, Bayer explained. To achieve NGSP certification, an A1C testing method must successfully complete rigorous testing requirements annually, the company noted.