Recognized standard
I/LA21-A2
FDA recognition 7-170 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-170 |
|---|---|
| Designation | I/LA21-A2 |
| Title | Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 18, 2009 |
| Scope (excerpt) | The elements of this guideline include: 1) a development plan for an effective analysis and evaluation; 2) a discussion of the planning and design considerations that are necessary for a successful evaluation; 3) a description of requirements for conducting the evaluation through monitoring and… |
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: