Sooil Dana Diabecare IISG

Device Name:

Dana Diabecare IISG

Manufacturer:

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

Description:

The Sooil Dana Diabecare IISG is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Legacy approval	Older clinical validation; older protocol
BG	MDR Criteria	Self-measurement	Published 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.