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Arkray Glucocard Sigma (GT-1070)
Device Model:
GT-1070
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
Device Manual:
Device Specifications:
Description:
The Arkray Glucocard Sigma (GT-1070) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:
The technology used in the Arkray Glucocard Sigma (GT-1070), 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★ Recommendation Recent clinical validation; recent protocol
MDR Criteria Self-measurement Published 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

15197:2011 - Pass General population