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Elta Satellite Express

Device Name:Satellite Express
Manufacturer:Sole: 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
Assessment:

The technology used in the Elta Satellite Express, 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

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

- 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

- Fail General population

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