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Bayer Contour Plus

Device Name:Contour Plus
Manufacturer:Sole: Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 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, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
MDR CriteriaProfessional use for adults and neonatesPublished evidence

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: PMC4604584.

15197:2013 - Pass Neonates

CLSI:2013 - Pass Neonates

FDA:2016P - Fail Neonates

Ji LN, Guo LX, Liu LB. Accuracy and precision assessment of a new blood glucose monitoring system. Clin Chem Lab Med.. 2016 Jan;54(1):181-8. doi: 10.1515/cclm-2015-0130. PMID: 26053011.

15197:2013 - Pass General population

Freckmann G, Baumstark A, Jendrike N, Rittmeyer D, Pleus S, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in the Hands of Intended Users and Trained Personnel Based on ISO 15197 Requirements. Diabetes Technol Ther. 2017 Apr;19(4):246-54. Epub: 2017 Feb 22. doi: 10.1089/dia.2016.0341. PMID: 28225633.

15197:2013 General population (Note: Results not in Abstract)