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Arkray Glucocard Sigma-Mini (GT-1060)

Device Name:Glucocard Sigma-Mini
Device Model:GT-1060
Manufacturer:Arkray Global Business Inc., 1408 Koji, Konan cho, koka shi, Shiga, JAPAN.
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 Arkray Glucocard Sigma-Mini (GT-1060), 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

Андрианова ЕА, Ильин АВ, Кураева ТЛ, Петеркова ВА. [Andrianova EA, Il’in AV, Kuraeva TL, Peterkova VA.] Оценка клинической безопасности и аналитической надежности средств самоконтроля уровня глюкозы в крови «Глюкокард Сигма» и «Глюкокард Сигма-мини» у пациентов детского возраста с сахарным диабетом 1-го типа [Evaluation of clinical safety and analytical accuracy of devices for self-monitoring of blood glucose Glucocard Sigma and Glucocard Sigma Mini in pediatric patients with type 1 diabetes mellitus] Проблемы эндокринологии [Problems of Endocrinology]. 2017;63(1):17-22. doi: 10.14341/probl201763117-22. Available from: www.mediasphera.ru.

15197:2013 - Pass General population

- Pass General population