Recognized standard
EP12-A2
FDA recognition 7-152 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-152 |
|---|---|
| Designation | EP12-A2 |
| Title | User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | This document contains a protocol that optimizes the experimental design for the evaluation of qualitative tests, to better measure performance and provide a structured data analysis. |
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: