All Medicus GlucoDr Auto (AGM-4000)
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 Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | ★★ Recommendation | Recent clinical validation; recent protocol | ||
| MDR Criteria | Self-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
