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

Device Specifications:

Click here to download the Device Specifications

Description:

The Arkray Glucocard Sigma-Mini (GT-1060) 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. It is intended for self-measurement and home use.

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★ Recommendation	Recent clinical validation; recent protocol
BG	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