Recognized standard
EP24-A2 (Replaces GP 10-A)
FDA recognition 7-234 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-234 |
|---|---|
| Designation | EP24-A2 (Replaces GP 10-A) |
| Title | Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | This document provides a protocol for evaluating the accuracy of a test to discriminate between two subclasses of subjects when there is some clinically relevant reason to separate them. In addition to the use of receiver operating characteristic curves and the comparison of two curves, the document… |
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: