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J&J OneTouch Select Simple

Device Name:OneTouch Select Simple
Manufacturer:Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, 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 J&J OneTouch Select Simple, 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; older protocol
MDR CriteriaPossiblyConfirmation required - Results not in abstract

Validation Publications

Philis-Tsimikas A, Chang A, Miller L. Precision, accuracy, and user acceptance of the OneTouch SelectSimple blood glucose monitoring system. J Diabetes Sci Technol. 2011 Nov 1;5(6):1602-9. doi: 10.1177/193229681100500638. PMID: 22226284.

15197:2003 - Pass General population

Freckmann G, Baumstark A, Jendrike N, Rittmeyer D, Pleus S, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in the Hands of Intended Users and Trained Personnel Based on ISO 15197 Requirements. Diabetes Technol Ther. 2017 Apr;19(4):246-54. Epub: 2017 Feb 22. doi: 10.1089/dia.2016.0341. PMID: 28225633.

15197:2013 General population (Note: Results not in Abstract)

Relevant Publications

Krouwer JS. Analysis of the performance of the OneTouch SelectSimple blood glucose monitoring system: why ease of use studies need to be part of accuracy studies. J Diabetes Sci Technol. 2011 Nov 1;5(6):1610-1. PMID: 22226285.

The publication is a letter or correspondence in which the J&J OneTouch Select Simple is referenced.