Recognized standard
EP27 2nd Edition
FDA recognition 7-313 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-313 |
|---|---|
| Designation | EP27 2nd Edition |
| Title | Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This guideline provides recommendations on constructing and using error grids to evaluate the clinical acceptability of quantitative measurement procedures, based on the potential harm that may be caused by erroneous measurements with clinical consequences. This guideline is intended for use by… |
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: