Bayer Contour

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

Harrison B, Leazenby C, Halldorsdottir S. Accuracy of the CONTOUR® blood glucose monitoring system. J Diabetes Sci Technol. 2011 Jul 1;5(4):1009-13. PMID: 21880245. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3192609/pdf/dst-05-1009.pdf.

15197:2003 - Pass General population

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.

15197:2003 - Fail General population

15197:2013 - Fail General population

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3876330/pdf/dst-07-1522.pdf.

15197:2003 - Fail Using insufficient blood samples (n=31)

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

15197:2003 - Pass General population

15197:2013 - Fail General population

Relevant Publications

Lv H, Zhang GJ, Kang XX, Yuan H, Lv YW, Wang WW, Randall R. Factors interfering with the accuracy of five blood glucose meters used in Chinese hospitals. J Clin Lab Anal. 2013 Sep;27(5):354-66. doi: 10.1002/jcla.21611. PMID: 24038220.

The publication evaluates the performance of the Bayer Contour, though not in a formal validation.