CLSI EP09c

Measurement Procedure Comparison and Bias Estimation Using Patient Samples

Body

CLSI

Number

CLSI EP09c

FDA recognition no.

7-296

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Chapter 2 Introduction to Measurement Procedure Comparison and Bias Estimation. Subchapter 2.2 Introduction. Subchapter 2.2.2.1 Establishing the Relationship between Measurement Procedures by the Manufacturer. Subchapter 2.2.2.2 Validation by the Manufacturer. Chapter 3 Preparing for the Measurement Procedure Comparison Study. Chapter 5 Visual Data Analysis. Chapter 6 Quantitative Analysis. Subchapter 6.1 Estimating Bias from Difference Plots. Subchapter 6.2.4 Aberrant Results. Subchapter 6.2.5 Nonlinear Distribution.

Scope source: FDA 认可共识标准库

Laboratories covering this standard