Analysis of the performance of the CONTOUR® TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients?

@article{Lyon2011AnalysisOT,
  title={Analysis of the performance of the CONTOUR® TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients?},
  author={Martha E. Lyon and Andrew W. Lyon},
  journal={Journal of diabetes science and technology},
  year={2011},
  volume={5 1},
  pages={206-8}
}
The article entitled, Performance of the CONTOUR® TS Blood Glucose Monitoring System, by Frank and colleagues in this issue of Journal of Diabetes Science and Technology, demonstrates that the CONTOUR® TS glucose meter exceeds current regulatory expectations for glucose meter performance. However, the appropriateness of current regulatory expectations, such as International Organization for Standardization (ISO) 15197:2003, is being reevaluated because of increasing concern regarding the… CONTINUE READING

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