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Sooil Dana Diabecare IISG

Device Name:Dana Diabecare IISG
Manufacturer:Sole: SOOIL Development Co. Ltd., 2725 Nambusunhwan-ro, Gangnam -gu, Seoul 135-504, REPUBLIC of KOREA.
Measuring functions:Insulin pump with integrated blood glucose meter
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 Sooil Dana Diabecare IISG, 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
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Fail General population (Note: Subject-recorded measurements)

FDA:2016H - Fail General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2008/66

SKUP. Report from the evaluation SKUP/2008/66: Dana DiabeCare 11SG (SOOIL Development Co.), a system for blood glucose measurement. Bergen, Norway: SKUP; 2008. 58 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.