Bayer Contour Plus

Device Name:Contour Plus
Manufacturer:Bayer Healthcare AG, 51368 Leverkusen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Bayer Contour Plus, to measure blood glucose, has passed in two validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

Caswell M, Frank J, Viggiani MT, Pardo S, Dunne N, Warchal-Windham ME, Morin R. Accuracy and user performance evaluation of a blood glucose monitoring system. Diabetes Technol Ther. 2015 Mar;17(3):152-8. Epub: 2014 Dec 10. doi: 10.1089/dia.2014.0129. PMID: 25494048.

15197:2003 - Pass General population

15197:2013 - Pass 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