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Evaluating the linearity of a measurement procedure (CLSI EP06-A)

Learn how to characterize the linearity of a measurement procedure for product performance characteristics, for FDA 510k submissions and product marketing.

In this tutorial you will use the CLSI EP06-A procedure to establish the linearity.

  1. Estimating linearity
    Estimate the linearity of the measurement procedure.
  2. Reducing the measuring interval
    Reduce the measuring interval to find the interval where the fit is linear.
Related information
CLSI. (2003). Evaluation of the Linearity of Quantitative Measurement Procedures (EP6-A). Clinical and Laboratory Standards Institute.

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  •  Estimating the precision of a measurement procedure (CLSI EP05-A3)
  •  Evaluating the linearity of a measurement procedure (CLSI EP06-A)
  •  Estimating linearity
  •  Reducing the measuring interval
  •  Verifying the precision of a measurement procedure against a performance claim and estimating the bias (CLSI EP15-A3)
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Version 6.15
Published 18-Apr-2023
statistics software, statistical software for Excel
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