Recognized standard
EP09c 3rd Edition
FDA recognition 7-296 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-296 |
|---|---|
| Designation | EP09c 3rd Edition |
| Title | Measurement Procedure Comparison and Bias Estimation Using Patient Samples |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This guideline provides recommendations for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on comparing patient samples. It provides both difference plot and regression procedures to determine the… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: