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Cambridge Sensors microdot+

Device Name:microdot+
Manufacturer:

Distributer: Cambridge Sensors Ltd., Units 9-10 Cardinal Park, Cardinal Way, Godmanchester, Huntingdon, Cambridgeshire PE29 2XG, UNITED KINGDOM.

Other: Cambridge Sensors USA LLC, 23866 W. Industrial Drive North, Plainfield, IL 60585, UNITED STATES.

Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Cambridge Sensors microdot+, 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

Yon Hin B, Bueno I, Lowe CR, Jones S. Clinical Accuracy Study of an GDH-NAD Blood Glucose Monitoring System Using the Performance Criteria of ISO 15197:2013. J Diabetes Sci Technol. 2017 Mar;11(2):444-5. Epub: 2016 Sep 25. doi: 10.1177/1932296816664362. PMID: 27578824. Available from: PMC5478022. No abstract available.

15197:2013 - Pass General population