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All Medicus GlucoDr Auto (AGM-4000)

Device Name:GlucoDr Auto
Device Model:AGM-4000
Manufacturer:All Medicus Co. Ltd., 7608 Dong-il Techno Town 7th, 823 Gwanyang 2 dong, Dongan-gu, Anyang-si, Gyeonggi-do 431-062, REPUBLIC of KOREA.
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 All Medicus GlucoDr Auto (AGM-4000), 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-measurement (Previous)Published evidence

Validation Publications

Jendrike N, Baumstark A, Kamecke U, Haug C, Freckmann G. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017 Nov;11(6):1275-6. Epub: 2017 Aug 29. doi: 10.1177/1932296817727550. PMID: 28849677. Available from: PMC5951056. No abstract available.

15197:2013 - Pass General population