AgaMatrix Wavesense Jazz
AgaMatrix Inc., 7C Raymond Avenue, Salem, NH 03079, UNITED STATES.
Primary Client Use:
Intended for self-measurement and home use
Finger and general Alternative Site Testing
Single measurements only
The AgaMatrix Wavesense Jazz is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
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.
|BG||Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|BG||TÜV SÜD (DE)||General use||Unpublished internal data|
|BG||MDR Criteria||Self-measurement||Published evidence|
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