Recognized standard
EP05-A3 (Reaffirmed: September 2019)
FDA recognition 7-251 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-251 |
|---|---|
| Designation | EP05-A3 (Reaffirmed: September 2019) |
| Title | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | This document provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures. |
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: