Recognized standard
I/LA30-A (Replaces I/LA30-P)
FDA recognition 7-176 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-176 |
|---|---|
| Designation | I/LA30-A (Replaces I/LA30-P) |
| Title | Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 18, 2009 |
| Scope (excerpt) | This standard presents information on the origin, nature, and prevalence of circulating endogenous antibodies, which cause interference with immunoassay results. The mechanisms of the interference along with some specific examples are included. To address the problem, recommendations for regulatory… |
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: