Recognized standard
EP27-A
FDA recognition 7-291 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-291 |
|---|---|
| Designation | EP27-A |
| Title | How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | This guideline describes what an error grid is, why it is useful, and how to construct and interpret the information. Guidance is provided for manufacturers and for the clinical laboratory. |
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: