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Roche Accu-Chek Inform II

Device Name:Accu-Chek Inform II
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 both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Roche Accu-Chek Inform II is a clinically validated and 3-star blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.

The technology used in the Roche Accu-Chek Inform II, 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-measurement and professional usePublished evidence

Validation Publications

Gijzen K, Moolenaar DL, Weusten JJ, Pluim HJ, Demir AY. Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit. Clin Chem Lab Med. 2012 Nov;50(11):1985-92. PMID: 22718643.

15197:2003 - Pass General population

Mitsios JV, Ashby LA, Haverstick DM, Bruns DE, Scott MG. Analytic evaluation of a new glucose meter system in 15 different critical care settings. J Diabetes Sci Technol. 2013 Sep 1;7(5):1282-7. doi: 10.1177/193229681300700518. PMID: 24124955. Available from: PMC3876372.

CLSI:2013 - Pass Critically ill patients

Ba Y, Xu J, Yuan L, Zhu H, Yang Y, Lam MM, Zhang S, Xiao M, Xu J, Zhang R, Chen C. Assessment of the performance of blood glucose monitoring systems for monitoring dysglycaemia in neonatal patients. BMJ Paediatr Open. 2018 Oct 23;2(1):e000339. doi: 10.1136/bmjpo-2018-000339. PMID: 30397671. Available from: PMC6203032. eCollection 2018.

CLSI:2013 - Fail Neonates (Note: Meter is susceptible to interference by low concentrations of galactose that could potentially influence the ability to detect hypoglycaemia.)

CMA:2016 Neonates

Kim HN, Moon KC, Yoon SY. Performance evaluation of three i-SENS glucometers using arterial blood samples compared with the YSI 2300 Glucose Analyzer. J Clin Lab Anal. 2020 Aug;34(8):e23356. Epub: 2020 May 19. doi: 101002/jcla23356. PMID: 32430994. Available from: PMC7439437.

15197:2013 - Pass General population (Note: Modified protocol: Fewer samples with low and high blood glucose concentrations than recommended. One reagent system lot.)

Relevant Publications

Joseph JI. Analysis: New point-of-care blood glucose monitoring system for the hospital demonstrates satisfactory analytical accuracy using blood from critically ill patients--an important step toward improved blood glucose control in the hospital. J Diabetes Sci Technol. 2013 Sep 1;7(5):1288-93. doi: 10.1177/193229681300700519. PMID: 24124956. Available from: PMC3876373.

The publication is a letter or correspondence in which the Roche Accu-Chek Inform II is referenced.

Jeong TD, Cho EJ, Ko DH, Lee W, Chun S, Hong KS, Min WK. Large-scale performance evaluation of Accu-Chek inform II point-of-care glucose meters. Scand J Clin Lab Invest. 2016 Dec;76(8):657-63. Epub: 2016 Oct 14. doi: 10.1080/00365513.2016.1233575. PMID: 27739331.

The publication evaluates the performance of the Roche Accu-Chek Inform II, though not in a formal validation.