IVD Medical Devices
See IVD Classification for the full classification overview.
IVD-specific submission considerations
When submitting a 510(k) for an IVD, the following are typically required in addition to the standard 510(k) sections:
- Analytical performance studies — precision, accuracy, linearity, interference, reference intervals
- Clinical performance studies — sensitivity, specificity, positive and negative predictive value vs. reference method
- Comparison to predicate — head-to-head performance comparison
- Intended use population — patient population, intended users (laboratory vs. lay person)
- CLIA category — proposed CLIA complexity categorisation with supporting data
Point-of-care and home-use IVDs
IVDs intended for use outside the clinical laboratory (POC or home use) face additional requirements:
- Human factors / usability testing with intended users (lay persons or non-laboratory healthcare workers)
- Simulated-use or actual-use studies
- Simplified instructions validated with target users