Abbott Optium Omega
Device Name:
Optium Omega
Manufacturer:
Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Abbott Optium Omega 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 Abbott Optium Omega, 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 |
Validation Publications:
Solnica B, Kusnierz-Cabala B, Slowinska-Solnica K, Witek P, Cempa A, Malecki MT. Evaluation of the analytical performance of the coulometry-based Optium Omega blood glucose meter. J Diabetes Sci Technol. 2011 Nov 1;5(6):1612-7. PMID: 22226286.
15197:2003 - Pass General population
ADA:1987 - Pass General population
Relevant Publications:
Krouwer JS. Evaluation of the analytical performance of the coulometry-based Optium Omega blood glucose meter: what do such evaluations show? J Diabetes Sci Technol. 2011 Nov 1;5(6):1618-20. PMID: 22226287.
The publication is a letter or correspondence in which the Abbott Optium Omega is referenced.