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.
What You Need to Know? 👇
What are the key performance requirements for OTC hCG pregnancy test 510(k) submissions?
FDA requires comparison studies with at least 100 fresh urine specimens, specificity testing against LH/FSH/TSH cross-reactivity, interference studies with drugs and biological analytes, sensitivity evaluation at 95% positive detection rate, and stability data for result interpretation timing.
How should sensitivity be evaluated for qualitative hCG pregnancy tests?
Sensitivity should be evaluated by spiking at least 30 clinical samples with six different hCG concentrations below, at, and above the stated sensitivity level. Include concentrations at -50% and -25% of sensitivity, with all positive results reacting within specified timeframes.
What labeling requirements apply to OTC pregnancy tests versus professional use devices?
OTC labeling should be concise and easy to understand, eliminating technical language. Formal sections like “Intended Use” and “Performance Characteristics” can be simplified within text without subheadings, focusing on clear illustrations and user-friendly descriptions of test function.
What cross-reactivity testing is required for hCG pregnancy test specificity?
Specificity studies must test specimens with high physiological concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), and thyroid stimulating hormone (TSH). Spiking samples demonstrates absence of cross-reactivity at elevated hormone levels.
How should OTC study design be structured for home pregnancy test validation?
Use at least 100 fresh human urine specimens split between subjects and professionals. Subjects should collect samples and perform tests without assistance, mimicking actual use. Include diverse users and questionnaires for feedback on ease of use and package insert clarity.
What internal quality control requirements exist for OTC hCG devices?
If devices contain procedural or design controls, their function must be described in detail (e.g., determining if chemicals work properly, adequate sample added, or proper procedure followed). Identify control components and state reference line sensitivity where applicable.
What You Need to Do 👇
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