Recognized standard
EP21 2nd Edition (Replaces EP21-A)
FDA recognition 7-268 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-268 |
|---|---|
| Designation | EP21 2nd Edition (Replaces EP21-A) |
| Title | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | This guideline provides manufacturers and end users with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and data analysis method are provided to estimate TAE based upon a comparison of methods experiment with… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: