Recognized standard
EP14-A3
FDA recognition 7-252 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-252 |
|---|---|
| Designation | EP14-A3 |
| Title | Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 14, 2015 |
| Scope (excerpt) | This guideline provides protocols that can evaluate commutability in any nonpatient processed samples when tested using quantitative measurement procedures. Such processed samples may be used for proficiency testing/external quality assessment (PT/EQA), measuring interval verification sample sets… |
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: