Omnis Embrace

Device Name:

Embrace

Manufacturer:

OBL: Omnis, 505 Airpark Center Drive, Nashville, TN 37217, UNITED STATES.

OEM: Apex Biotechnology Corp., 7 Li-Hsin Road V, Hsinchu Science Park, Hsinchu 30078, TAIWAN ROC.

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

Device Manual:

Click here to download the Device Manual

Description:

The Omnis Embrace 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 both professional use and self-measurement.

Assessment:

The technology used in the Omnis Embrace, 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:

Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013 Jan 1;7(1):144-52. doi: 10.1177/193229681300700117. PMID: 23439170. Available from: PMC3692226.

15197:2003 - Fail General population

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.

DTS:2016 - Fail General population