Recognized standard
POCT05 2nd Edition
FDA recognition 7-307 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-307 |
|---|---|
| Designation | POCT05 2nd Edition |
| Title | Performance Metrics for Continuous Interstitial Glucose Monitoring |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This guideline provides recommendations for methods used to determine analytical and clinical metrics of continuous glucose monitoring (CGM) as an indicator of blood glucose values. It discusses use cases, point accuracy, trend accuracy, evaluation of threshold alerts, system stability and… |
At a glance
- 10–99 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: