Roche Accu-Chek Nano
Device Name:
Accu-Chek Nano
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
Availability according to Countries or Regions:
United States
Description:
The Roche Accu-Chek Nano is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. 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 Nano, to measure blood glucose, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. However, it was also assessed in another study, but the results have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |
| Consumer Body | Year(s) | Level | Comment | |
| BG | Consumer Reports (US) | Previous: 2019 | Very Good |
Validation Publications:
Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.
DTS:2016 - Fail General population
The paper refers to the "Accu-Chek Smart View". These are the strips used by the Accu-Chek Nano.