Osang GluNEO

Device Name:

GluNEO

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 self-measurement and home use

Measurement Site:

Finger and general Alternative Site Testing

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Osang GluNEO is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.

Assessment:

The technology used in the Osang GluNEO, to measure blood glucose, has failed 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	Not recommended	This device has failed a clinical validation.
BG	Institute of Health Economics (CA)	General use	No evidence provided

Validation Publications:

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Fail General population (Note: Modified protocol: One reagent system lot.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Fail General population