Recognized standard
AUTO09-A
FDA recognition 7-339 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-339 |
|---|---|
| Designation | AUTO09-A |
| Title | Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | The CLSI AUTO09 standard provides essential guidance for managing, validating, and ensuring the integrity of laboratory test data efficiently. Designed for laboratory professionals, IT specialists, and regulatory compliance teams, this standard outlines best practices for data handling and system… |
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: