Roche Accu-Chek Inform II

Device Name:Accu-Chek Inform II
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 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 Roche Accu-Chek Inform II, to measure blood glucose, has passed in a validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Validation Publications

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: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876372/pdf/dst-07-1282.pdf.

CLSI:2013 - Pass Critically ill patients

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: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876373/pdf/dst-07-1288.pdf.

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.