Recognized standard
EP46 1st Edition
FDA recognition 7-351 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-351 |
|---|---|
| Designation | EP46 1st Edition |
| Title | Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | CLSI EP46 provides guidance for selecting the relevant sources for establishing allowable total error (ATE) goals and/or limits for quantitative medical laboratory measurement procedures. This guidance is suitable for both commercial products as well as laboratory-developed tests (LDTs). It is… |
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: