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Infopia Finetest (IGM-0005A)

Device Name:Finetest
Device Model:IGM-0005A
Manufacturer:Osang HealthCare (Infopia), 132 Anyangcheondong-ro, Dongan-gu, Anyang-si, Gyeonggi-do, REPUBLIC of KOREA.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Infopia Finetest (IGM-0005A) is a clinically validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:

The technology used in the Infopia Finetest (IGM-0005A), 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
MedavalLegacy approvalOlder clinical validation; older protocol

Validation Publications

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population