IVD Classification — Class A · B · C · D
IVDs are classified under TR-004 based on user expertise, clinical impact, and intended purpose.
| Class | Risk | Examples | MDACS |
|---|---|---|---|
| A | Low | General lab instruments, culture media | ❌ Not eligible |
| B | Moderate-low | Pregnancy tests, blood glucose self-tests | ✅ Eligible |
| C | Moderate-high | HIV confirmatory, hepatitis B surface antigen | ✅ Eligible |
| D | High | Blood donor screening for HIV, hepatitis C, West Nile | ✅ Eligible |
IVD vs General Device Documentation
Performance evaluation (sensitivity, specificity, precision data) is required for IVDs instead of the clinical evaluation report used for general devices. See Pre-Market Requirements.