Roche Accu-Chek Instant

Device Name:

Accu-Chek Instant

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 self-measurement and home use

Measurement Site:

Finger and general Alternative Site Testing

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Roche Accu-Chek Instant is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.

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 two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	TÜV Rheinland Nederland	General use	Unpublished internal data
BG	MDR Criteria	Self-measurement	Published 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):854-855. Epub: 2016 Dec 1. doi: 10.1177/1932296816682032. PMID: 28625090. Available from: PMC5588821.

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)