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.
Recommended Actions
- Develop comprehensive testing protocol covering sensitivity, specificity, and interference studies
- Design and conduct OTC user study with diverse population of at least 100 participants
- Prepare simplified labeling documentation suitable for OTC use while maintaining compliance with regulations
- Document antibody characterization and quality control procedures
- Validate all testing procedures if multiple methods are offered
- Create user questionnaire to gather feedback on usability and instructions clarity
- Prepare complete 510(k) submission package including all required performance data and labeling
- Ensure accuracy claims are properly supported and not overstated
- Implement appropriate stability testing program for reagents and results interpretation
- 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
- Antibody characterization and purification information required
- Quality control information must be documented
- Storage conditions specified (2-8°C for up to 48 hours if not tested immediately)
Relevant Guidances
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Device Labeling Requirements and Content for Premarket Approval Applications
- In Vitro Diagnostic Devices for Detection of Antibodies to Borrelia burgdorferi - Performance Characteristics and Testing Requirements
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms
- 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
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