Recognized standard
C56-A
FDA recognition 7-242 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-242 |
|---|---|
| Designation | C56-A |
| Title | Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 1 |
| Scope (excerpt) | This document focuses on the intended usefulness and challenging issues of hemolysis, icterus, and lipemia/turbidity (HIL) indices as estimates of interference that may impact the validity and clinical utility of reportable patient results. C56 is closely aligned with CLSI document EP07; thus, the… |
At a glance
- 1–9 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: