Abbott Optium Xceed

Device Name:Optium Xceed
Manufacturer:Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:Blood glucose, Ketones
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
Assessment: The technology used in the Abbott Optium Xceed, to measure blood glucose, has passed in two validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

Coyne S, Lacour B, Hennequin-Le Meur C. Évaluation des lecteurs de glycémie Optium Xceed (Abbott) et One Touch Ultra (Lifescan). [Evaluation of the Optium Xceed (Abbott) and One Touch Ultra (Lifescan) glucose meters.] Ann Biol Clin (Paris). 2008 May-Jun;66(3):249-54. doi: 10.1684/abc.2008.0223. PMID: 18558561. French.

Ad Hoc protocol General population

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

Jday-Daly I, Augereau-Vacher C, De Curraize C, Fonfrède M, Lefevre G, Lacour B, Hennequin-Le Meur C. Évaluation multicentrique de la fiabilité de cinq lecteurs de glycémie. [Multicenter evaluation of the reliability of five blood glucose monitoring systems.] Ann Biol Clin (Paris). 2011 Jan-Feb;69(1):55-61. doi: 10.1684/abc.2010.0509. PMID: 21463996. French.

15197:2003 - Fail General population

Robinson CS, Sharp P. Tighter accuracy standards within point-of-care blood glucose monitoring: how six commonly used systems compare. J Diabetes Sci Technol. 2012 May 1;6(3):547-54. PMID: 22768885.

15197:2003 - Pass General population

CLSI: 2002 - Pass General population

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3876330/pdf/dst-07-1522.pdf.

15197:2003 - Fail Using insufficient blood samples (n=31)