Bayer Contour Next EZ

Device Name:Contour Next EZ
Manufacturer:Bayer Healthcare AG, 51368 Leverkusen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Bayer Contour Next EZ, to measure blood glucose, has passed in a validation study, in a young population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a general population, according to a non-standard protocol.
Validation Publications

Halldorsdottir S, Warchal-Windham ME, Wallace JF, Pardo S, Parkes JL, Simmons DA. Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1294-304. doi: 10.1177/193229681300700520. PMID: 24124957. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876374/pdf/dst-07-1294.pdf.

Ad Hoc protocol General population

Dietzen DJ, Nenninger DA, Simmons DA, Pardo S, Pandya M, Fullam J. Analytic characteristics of three Bayer contour blood glucose monitoring systems in neonates. J Diabetes Sci Technol. 2015 Mar;9(2):257-61. Epub: 2014 Nov 4. doi: 10.1177/1932296814557669. PMID: 25377056. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604584/pdf/10.1177_1932296814557669.pdf.

15197:2013 - Pass Neonates

CLSI:2013 - Pass General population

FDA:2016P - Fail General population

Relevant Publications

Fournier PA. Analysis of "Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial". J Diabetes Sci Technol. 2013 Sep 1;7(5):1305-7. doi: 10.1177/193229681300700521. PMID: 24124958. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876375/pdf/dst-07-1305.pdf.

The publication is a letter or correspondence in which the Bayer Contour Next EZ is referenced.