Elta Satellite Express
Device Name:
Satellite Express
Manufacturer:
ООО Компания ЭЛТА (Elta Company Ltd.), стр. 4, д. 3 ул. Конструктора Гуськова, Зеленоград, Москва 124460 (Building 4, 3 Konstruktora Guskova St., Zelenograd, Moscow 124460), RUSSIAN FEDERATION.
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
Description:
The Elta Satellite Express 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 Elta Satellite Express, to measure blood glucose, has passed in two clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★ Recommendation Older clinical validation; recent protocol; multiple clinical validations
BG MDR Criteria Self-measurement Published evidence
Validation Publications:

Пашинцева ЛП, Бардина ВС, Ильясов ИР, Мищенко БП, Анциферов МБ. [Pashintseva LP, Bardina VS, Il'iasov IR, Mishchenko BP, Antsiferov MB.] Клинико-Лабораторная Оценка Точности Портативных Глюкометров "Сателлит Экспресс" и "Сателлит Экспресс Мини" [The clinical laboratory evaluation of accuracy of portable glucometers "Satellite Express" and "Satellite Express mini".] клин лаб диагностика [Klin Lab Diagn]. 2011 Nov;[56](11):33-5. PMID: 22312913. In Russian.

15197:2013 - Pass General population

Хайбулина ЭТ, Мамонов РА, Горст КА, Тимофеев АВ. [Khaibulina ET, Mamonov RA, Gorst KA, Timofeev AV.] Оценка аналитической и клинической точности трех систем контроля уровня глюкозы в крови [Evaluation of the analytical and clinical accuracy of three blood glucose monitoring systems] Эффективная фармакотерапия. Эндокринология No 6 [Effective Pharmacotherapy. Endocrinology No 6]. 2014;2014(53):22-7. In Russian.

15197:2013 - Fail General population

15197:2011 - Fail General population

Хоровская ЛА, Лобачевская ТВ, Черничук ОВ. [Horovskaia LA, Lobachevskaia TV, Chernichuk OV.] Аналитическое Качество и Оценка Сопоставимости Четырех Глюкометров Разных Производителей [The analytical quality and comparability value of four glucometers from different manufacturers.] клин лаб диагностика [Klin Lab Diagn.]. 2015 Jan;60(1):60-3. PMID: 25874308. Available from: cyberleninka.ru. In Russian.

15197:2013 - Fail General population

Тимофеев АВ, Хайбулина ЭТ, Мамонов РА, Горст КА. [Timofeev AV, Khaibulina ET, Mamonov RA, Gorst KA.] Проверка аналитических характеристик трех моделей глюкометров. [The verification of analytical characteristics of three models of glucometers.] клин лаб диагностика [Klin Lab Diagn]. 2016 Jan;61(1):39-45. PMID: 27183728. In Russian.

15197:2013 - Fail General population

15197:2011 - Fail General population

Second publication of results. See: Effective Pharmacotherapy. Endocrinology No 6. 2014;2014>(53):22-27.

Дианов ОА, Мальцев ВВ, Мурина ЕС, Анфилов ИС. [Dianov OA, Maltsev VV, Murina ES, Anfilov IS.] Оценка точности при использовании глюкометра Сателлит Экспресс для контроля гликемии у детей с сахарным диабетом. [Accuracy assessment of the blood glucose meter «Satellite Express» for glycemic control in children with diabetes.] Проблемы Эндокринологии [Probl Endokrinol (Mosk)]. 2020 Jun 10;65(6):436-443. Epub: 2019. doi: 10.14341/probl12311. PMID: 33351326. Available from: www.probl-endojournals.ru. In Russian.

15197:2013 - Pass Children

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