Recognized standard
I/LA-20 3rd Edition (Replaces I/LA20-A3)
FDA recognition 7-270 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-270 |
|---|---|
| Designation | I/LA-20 3rd Edition (Replaces I/LA20-A3) |
| Title | Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | This report provides guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human immunoglobulin E antibodies of defined allergen specificity. |
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: