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Over-the-Counter Pregnancy Test Devices - 510k Submission Requirements and Performance Standards

This guidance provides recommendations for manufacturers submitting 510(k) applications for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) pregnancy test devices. It covers performance requirements, testing protocols, and labeling considerations for home-use pregnancy tests that qualitatively measure hCG in urine.

  1. Develop comprehensive testing protocol covering sensitivity, specificity, and interference studies
  2. Design and conduct OTC user study with diverse population of at least 100 participants
  3. Prepare simplified labeling documentation suitable for OTC use while maintaining compliance with regulations
  4. Document antibody characterization and quality control procedures
  5. Validate all testing procedures if multiple methods are offered
  6. Create user questionnaire to gather feedback on usability and instructions clarity
  7. Prepare complete 510(k) submission package including all required performance data and labeling
  8. Ensure accuracy claims are properly supported and not overstated
  9. Implement appropriate stability testing program for reagents and results interpretation
  10. Include clear limitations and warnings in user instructions

Key Considerations

Clinical testing

  • Comparison study with at least 100 fresh human urine specimens
  • Study should include both professional users and OTC users
  • Subjects should represent diversity of age, background, and education
  • First-morning urine specimens recommended for testing

Non-clinical testing

  • Sensitivity/detection limit testing with at least 30 clinical samples at 6 different hCG concentrations
  • Specificity testing with high concentrations of LH, FSH, and TSH
  • Interference studies with prescription/OTC drugs, chemical analytes, biological analytes
  • Stability testing for reagents and result interpretation timeframe
  • Calibration against reference materials (1st IRP, 2nd IS, or 3rd IS)

Human Factors

  • OTC users should perform testing without assistance
  • Questionnaire required for user feedback on test ease of use and package insert clarity
  • For devices with multiple testing procedures (e.g., urine stream and dip), 50+ OTC users should validate each method

Labeling

  • Package insert must be concise and easy to understand
  • Clear illustrations and drawings required
  • Simplified technical language for OTC use
  • Must include limitations, control function description, and result interpretation timeframe
  • Avoid misleading accuracy statements (never exceed >99%)

Safety

  • Internal control requirements to verify proper test function
  • Maximum result interpretation time must be specified
  • Clear warnings about false results and limitations

Other considerations

  • NCCLS GP14-P: Labeling of Home-Use In Vitro Testing Products
  • 21 CFR §862.1155: Classification regulation for hCG test systems
  • 21 CFR §809.10: Labeling regulations

Original guidance

  • Over-the-Counter Pregnancy Test Devices - 510k Submission Requirements and Performance Standards
  • HTML / PDF
  • Issue date: 2000-07-21
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: d73893f20c548041559638727ee4a7d2
This post is licensed under CC BY 4.0 by the author.