AgaMatrix Wavesense Jazz
Device Name:
Wavesense Jazz
Manufacturer:
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
Device Manual:
Description:
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.
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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
| BG | TÜV SÜD (DE) | General use | Unpublished internal data |
| BG | MDR Criteria | Self-measurement | Published 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