Recognized standard
EP06 2nd Edition
FDA recognition 7-306 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-306 |
|---|---|
| Designation | EP06 2nd Edition |
| Title | Evaluation of the Linearity of Quantitative Measurement Procedures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jun 7, 2021 |
| Scope (excerpt) | This guideline provides recommendations for designing, analyzing, and interpreting linearity studies for quantitative measurement procedures. This guideline is intended for manufacturers and developers seeking to validate the linearity of a measurement procedure throughout a stated concentration… |
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: