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Applying Previously Cleared IVD Assays to Additional Automated Laboratory Instruments

This guidance pertains to In Vitro Diagnostic (IVD) test systems regulated by CDRH and comprised of a cleared assay that runs on an automated laboratory instrument specified by the assay manufacturer. It specifically addresses the application of a previously cleared assay to an additional instrument that was either previously cleared or is a member of an instrument family from which another member has been cleared. The guidance does not apply to: - Modifications other than application of cleared assay to additional instrument - Class III devices - Blood banking devices - Home use devices (prescription or OTC) - CLIA-waived test systems

  1. Confirm assay and instrument are previously cleared or part of cleared instrument family
  2. Assess if changes affect:
    • Key components or fundamental test principles
    • Instrument and software principles
    • Indications for use
  3. Conduct risk assessment to identify new/modified risks
  4. Perform verification/validation testing:
    • Use established protocols and acceptance criteria
    • Document results and justifications
    • Consider need for clinical validation
  5. Update labeling as needed
  6. Document changes and assessments in device master record
  7. Submit CLIA categorization request if proceeding without new 510(k)
  8. Consider consulting FDA if unclear about applicability to specific technology

Key Considerations

Clinical testing

  • Clinical validation may be needed in some cases when analytical validation alone is not adequate
  • If clinical study is necessary, a new 510(k) is likely required

Non-clinical testing

  • Verification and validation testing should be based on manufacturer’s quality processes and risk assessment
  • Testing protocols should be sufficiently robust to identify significant performance changes
  • Acceptance criteria should be clinically justified
  • Sample sizes should be statistically justified if different from original 510(k)

Software

  • Software modifications for system integration, signal processing, data acquisition or interpretation likely require new 510(k)
  • Software validation required per FDA guidance

Labeling

  • Must comply with 21 CFR parts 801 and 809
  • Package inserts must include procedural steps for new instrument
  • Application sheets should be referenced in package insert
  • Clearly state which instruments were tested
  • Update operator manuals with new specifications

Other considerations

  • CLSI EP-17: Detection capability
  • CLSI EP-05: Precision evaluation
  • CLSI EP-06: Linearity evaluation
  • CLSI EP-07: Interference testing
  • CLSI EP-09: Method comparison
  • CLSI EP-35: Matrix equivalence studies

Original guidance

  • Applying Previously Cleared IVD Assays to Additional Automated Laboratory Instruments
  • HTML / PDF
  • Issue date: 2022-08-17
  • Last changed date: 2022-08-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Laboratory Tests
  • ReguVirta summary file ID: 5aa6f0ed4878ede86b14156ff9b30cbb
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