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AgaMatrix Wavesense Jazz

Device Name:Wavesense Jazz
Manufacturer:Sole: AgaMatrix Inc., 7C Raymond Avenue, Salem, NH 03079, UNITED STATES.
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 AgaMatrix Wavesense Jazz, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Fail General population

15197:2013 - Fail General population

Grant DA, Dunseath GJ, Bain SC, Luzio S. Postmarket Approval Surveillance of a Low Acquisition Cost Blood Glucose Monitoring System: Assessment of the Accuracy Following ISO 15197:2013. J Diabetes Sci Technol. 2016 Sep;10(5):1195-6. Epub: 2016 May 12. doi: 10.1177/1932296816648991. PMID: 27179012. Available from: PMC5032959.

15197:2013 - Pass General population