Recognized standard
AUTO13-A2 (Formerly GP19-A2)
FDA recognition 7-345 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-345 |
|---|---|
| Designation | AUTO13-A2 (Formerly GP19-A2) |
| Title | Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | Identifies important factors that designers & laboratory managers should consider when developing new software-driven systems & selecting software user interfaces. Also included are simple rules to help prepare validation protocols. |
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: