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Roche Accu-Chek Performa Nano

Device Name:Accu-Chek Performa Nano
Manufacturer:Sole: Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, 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
Assessment:

The technology used in the Roche Accu-Chek Performa Nano, 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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

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: PMC3570840.

15197:2003 - Pass General population

15197:2013 - Pass General population

Baumstark A, Jendrike N, Pleus S, Haug C, Freckmann G. Evaluation of Accuracy of Six Blood Glucose Monitoring Systems and Modeling of Possibly Related Insulin Dosing Errors. Diabetes Technol Ther. 2017 Oct;19(10):580-8. Epub: 2017 Jul 13. doi: 10.1089/dia.2016.0408. PMID: 28704063.

15197:2013 General population

Six devices were validated in the study (the Roche Accu-Chek Aviva Nano, the Roche Accu-Chek Mobile, the Roche Accu-Chek Performa Nano, the Ascensia Contour Next Link 2.4, the Abbott FreeStyle Lite and the J&J LifeScan OneTouch Verio IQ). According to the abstract, one of them failed but it does not state which one.