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Roche Accu-Chek Inform

Device Name:Accu-Chek Inform
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
Measurement Occurrence:Single measurements only
Availability:Obsolete
Assessment:

The technology used in the Roche Accu-Chek Inform, to measure blood glucose, has been assessed, in a specific population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
MDR CriteriaAdultsValidation with amended protocol - may require further study

Validation Publications

Cho J, Ahn S, Yim J, Cheon Y, Jeong SH, Lee SG, Kim JH. Influence of Vitamin C and Maltose on the Accuracy of Three Models of Glucose Meters. Ann Lab Med. 2016 May;36(3):271-4. doi: 10.3343/alm.2016.36.3.271. PMID: 26915620. Available from: PMC4773272. Letter.

15197:2013 Validation with maltose interference (Note: No significant intereference at any maltose concentration was noted.)

15197:2013 Validation with high Vit C (30 mg/dl) concentrations (Note: Positive bias at high Vit C concentrations)

Relevant Publications

Lv H, Zhang GJ, Kang XX, Yuan H, Lv YW, Wang WW, Randall R. Factors interfering with the accuracy of five blood glucose meters used in Chinese hospitals. J Clin Lab Anal. 2013 Sep;27(5):354-66. doi: 10.1002/jcla.21611. PMID: 24038220.

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

Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. Diabetes Technol Ther. 2014 Dec;16(12):828-32. Epub: 2014 Aug 5. doi: 10.1089/dia.2014.0074. PMID: 25093919.

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