Performance Evaluation for IVDs

IVD devices require performance evaluation rather than clinical evaluation.

Components

• Analytical performance: accuracy, precision, linearity, interference, cross-reactivity, reference intervals
• Clinical performance: sensitivity, specificity, PPV, NPV vs reference method
• Scientific validity: evidence that the analyte has the claimed clinical relevance

By grade

Grade	Requirements
A/B	Analytical performance data; literature review
C/D	Formal clinical performance studies; reference laboratory confirmation

Companion diagnostics

Require coordination with the drug's approval process — MFDS pharmaceutical division consulted. See Companion diagnostics.