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i-Sens Alphacheck Professional

Device Name:Alphacheck Professional
Manufacturer:i-Sens Inc., 43 Banpo-daero 28-gil, Seocho-gu, Seoul 06646, 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 i-Sens Alphacheck Professional, 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

Link M, Pleus S, Schmid C, Freckmann G, Baumstark A, Stolberg E, Haug C. Accuracy Evaluation of Three Systems for Self-monitoring of Blood Glucose With Three Different Test Strip Lots Following ISO 15197. J Diabetes Sci Technol. 2014 Mar;8(2):422-4. Epub: 2014 Mar 24. doi: 10.1177/1932296813518859. PMID: 24876597. Available from: PMC4455421.

15197:2003 - Pass General population

15197:2013 - Pass General population