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Roche Accu-Chek Instant

Device Name:Accu-Chek Instant
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 and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Roche Accu-Chek Instant, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

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

Validation Publications

Breitenbeck N, Brown A. Accuracy Assessment of a Blood Glucose Monitoring System for Self-Testing with Three Test Strip Lots Following ISO 15197:2013/EN ISO 15197:2015. J Diabetes Sci Technol. 2017 Jul;11(4):854-5. Epub: 2016 Dec 1. doi: 10.1177/1932296816682032. PMID: 28625090. Available from: PMC5588828.

15197:2013 - Pass General population

SKUP. Report from the evaluation SKUP/2017/113: Accu-Chek Instant (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2017. 47 p. Available from: skup.org.

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

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

15197:2003 - Pass General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements)