Recognized standard
EP12 3rd Edition
FDA recognition 7-315 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-315 |
|---|---|
| Designation | EP12 3rd Edition |
| Title | Evaluation of Qualitative, Binary Output Examination Performance |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | EP12 provides product design guidance and protocols for performance evaluation of the Establishment and Implementation Stages of the Test Life Phases Model of examinations (see CLSI document EP191). EP12 characterizes a target condition (TC) with only two possible outputs (eg, positive or negative… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: