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Ascensia Contour Next EZ (Bayer)
Device Name:
Contour Next EZ
Manufacturer:
Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 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
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Ascensia Contour Next EZ (Bayer) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
Assessment:
The technology used in the Ascensia Contour Next EZ (Bayer), to measure blood glucose, has passed in a clinical 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval Recommended for children only Validation in children
BG Institute of Health Economics (CA) General use No evidence provided
BG MDR Criteria Neonates Published evidence
Consumer BodyYear(s)LevelComment
BG Amazon Best Sellers (US) Latest: 2019 A (4.1 / 5)
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: PMC3876374.

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: PMC4604584.

15197:2013 - Pass Neonates

CLSI:2013 - Pass Neonates

FDA:2016P - Fail Neonates

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: PMC3876375.

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