Roche Accu-Chek Performa

Device Name:Accu-Chek Performa
Manufacturer:Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.
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
Assessment: The technology used in the Roche Accu-Chek Performa, to measure blood glucose, has passed in four validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Validation Publications

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

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: www.ncbi.nlm.nih.gov/pmc/articles/PMC3570840/pdf/dst-06-1060.pdf.

15197:2003 - Pass General population (Note: Maltose dependent test strip)

15197:2013 - Pass General population (Note: Maltose dependent test strip)

15197:2003 - Pass General population (Note: Maltose independent test strip)

15197:2013 - Pass General population (Note: Maltose independent test strip)

Pleus S, Schmid C, Link M, Baumstark A, Haug C, Stolberg E, Freckmann G. Accuracy assessment of two novel systems for self-monitoring of blood glucose following ISO 15197:2013. J Diabetes Sci Technol. 2014 Jul;8(4):906-8. Epub: 2015 Ma5 25. doi: 10.1177/1932296814536030. PMID: 24876447. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4764206/pdf/10.1177_1932296814536030.pdf.

15197:2013 - Pass General population

Relevant Publications

Thompson H, Chan H, Logan FJ, Heenan HF, Taylor L, Murray C, Florkowski CM, Frampton CM, Lunt H. A glucose meter evaluation co-designed with both health professional and consumer input. NZ Med J. 2013 Nov 22;126(1386):90-7. doi: .. PMID: 24316996.

Measurements from the Roche Accu-Chek Performa are compared to those from the i-Sens CareSens N POP, though not in a formal validation.