Home /  i-Sens alphacheck professional

i-Sens alphacheck professional

Device Name:alphacheck professional
Manufacturer:Sole: i-Sens Inc., 43 Banpo-daero 28-gil, Seocho-gu, Seoul 06646, REPUBLIC of KOREA.
Measuring functions:Blood glucose
Primary Client Use:Intended for professional use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Description: The i-Sens alphacheck professional is a clinically validated and 2-star blood glucose meter. Measurements are taken from the finger and it is intended for professional use. This device has been discontinued by the manufacturer but may be available through certain outlets.
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
TÜV SÜD (DE)General useUnpublished internal data
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