J&J OneTouch Verio

Device Name:OneTouch Verio
Manufacturer:Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, 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 J&J OneTouch Verio, to measure blood glucose, has passed in three validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
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: www.ncbi.nlm.nih.gov/pmc/articles/PMC3570840/pdf/dst-06-1060.pdf.

15197:2003 - Pass General population

15197:2013 - 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 - Pass Using insufficient blood samples (n=31)

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: http://clinchem.aaccjnls.org/content/clinchem/61/5/772.full.pdf.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Fail General population (Note: Subject-recorded measurements)

FDA:2016H - Fail General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2011/86

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen MP, Bailey TS, Nichols JH, Kohn MA. Blood Glucose Monitoring System Surveillance Program. https://www.diabetestechnology.org/surveillance.shtml [Internet] Burlingame, CA: Diabetes Technology Society; 2017 Jun 23.

DTS:2016 - Fail General population

Relevant Publications

Littmann K, Petersen ER, Pussinen C, Danielson K, Djurisic S, Eilertsen H, Garabet L, Greibe E, Lauritzen T, Olsen DA, Othman S, Palimaru I, Westerlund J. Evaluation of OneTouch Verio®, a new blood glucose self-monitoring system for patients with diabetes. Scand J Clin Lab Invest. 2013;73(4):286-92. Epub: 2013 Mar 11. doi: 10.3109/00365513.2013.773064. PMID: 23473019.

This is a supplementary presentation of validation results for the J&J OneTouch Verio .

SKUP Evaluation 2011/86. See Sølvik et al. 2015

Teodorczyk M, Nandagopalan S, Maguire P, Stegmann J. System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards. J Diabetes Sci Technol. 2013 May 1;7(3):795-7. doi: 10.1177/193229681300700325. PMID: 23759413. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3869148/pdf/dst-07-0795.pdf.

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

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. In response to Teodorczyk and coauthors: System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards. J Diabetes Sci Technol. 2013 Nov 1;7(6):1659-60. doi: 10.1177/193229681300700632. PMID: 24351198. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876350/pdf/dst-07-1659.pdf.

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

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. In response to Teodorczyk and coauthors: System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards. J Diabetes Sci Technol. 2013 Nov 1;7(6):1659-60. doi: 10.1177/193229681300700632. PMID: 24351198. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876350/pdf/dst-07-1659.pdf.

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