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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

Official resources​

CLIA Complexity Category Impact on Submission

The proposed CLIA complexity category affects the premarket submission pathway. CLIA-waived IVDs may qualify for abbreviated 510(k) submissions, while moderate and high complexity tests typically require more comprehensive clinical performance data. Clearly identify the proposed CLIA category in your submission and provide justification with supporting analytical and clinical validation data.