Recognized standard
AUTO04-A
FDA recognition 7-333 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-333 |
|---|---|
| Designation | AUTO04-A |
| Title | Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This document describes operational requirements, characteristics, and required information elements of clinical laboratory automation systems. This information is used to determine the status of a clinical specimen within the clinical laboratory automation system, as well as the status of the… |
At a glance
- 1–9 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: