Recognized standard
EP28-A3c (Formerly C28-A3c)
FDA recognition 7-224 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-224 |
|---|---|
| Designation | EP28-A3c (Formerly C28-A3c) |
| Title | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | This document offers a protocol for determining reference intervals that meet the minimum requirements for reliability and usefulness. The guideline focuses on health-associated reference values as they relate to quantitative clinical laboratory tests. Included are various requirements for studies… |
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: