Ascensia Breeze (Bayer)
The technology used in the Ascensia Breeze (Bayer), to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
|Medaval||Legacy approval||Older clinical validation; older protocol|
Garg SK, Carter JA, Mullen L, Folker AC, Parkes JL, Tideman AM. The clinical performance and ease of use of a blood glucose meter that uses a 10-test disk. Diabetes Technol Ther. 2004 Aug;6(4):495-502. PMID: 15321005.
15197:2003 - Pass General population
Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.
15197:2013 - Fail General population