Disclaimer

Last Updated: February 15, 2026

FDA Disclaimer

Lab Sage is not a medical device as defined by the U.S. Food and Drug Administration (FDA). Lab Sage has not been evaluated, cleared, approved, or authorized by the FDA. The Service is not intended to diagnose, treat, cure, or prevent any disease or medical condition.

Lab Sage is designed as a clinical decision support tool intended to be exempt from medical device regulation under Section 3060 of the 21st Century Cures Act. The Service provides general health information and educational content that is intended to be used alongside — not in place of — professional medical judgment.

Statements and interpretations generated by Lab Sage have not been evaluated by the FDA. The information provided should not be used as a substitute for professional medical advice, diagnosis, or treatment.

AI Limitations & Accuracy

Lab Sage uses artificial intelligence (AI) models to analyze and interpret laboratory test results. It is important to understand the following limitations:

• AI can make errors. The interpretations generated by Lab Sage may be incomplete, inaccurate, or inappropriate for your specific health situation.
• No complete clinical picture. Lab Sage does not have access to your full medical history, current medications, symptoms, physical examination findings, imaging results, or other critical diagnostic information.
• Inconsistent outputs. AI models may produce different interpretations of the same data at different times.
• Not peer-reviewed. Individual AI-generated interpretations are not reviewed by a human physician before being presented to you.
• Training data limitations. AI models are trained on historical data that may not reflect the most current medical knowledge, your specific demographic, or rare conditions.
• No emergency detection. While Lab Sage attempts to flag critical values, it should never be relied upon for emergency detection. If you believe you are experiencing a medical emergency, call 911 immediately.

Educational Use Only

All content provided by Lab Sage — including lab interpretations, optimal range comparisons, pattern detection, lifestyle recommendations, and suggested questions for your healthcare provider — is provided solely for educational and informational purposes.

The use of terms such as "optimal," "suboptimal," "concerning," or "critical" in Lab Sage's analysis represents functional medicine perspectives on lab values and does not constitute a clinical diagnosis or medical opinion.

Lab Sage's "optimal ranges" are based on functional medicine principles and may differ from conventional medical reference ranges. These ranges represent one clinical perspective and should be discussed with your healthcare provider in the context of your complete health picture.

Not a Substitute for Professional Care

Lab Sage is not a substitute for the care, judgment, and expertise of a qualified healthcare provider. You should:

• Never rely solely on Lab Sage for health decisions
• Never delay seeking medical care because of information from Lab Sage
• Never start, stop, or change medications based on Lab Sage analysis
• Never use Lab Sage as an emergency health tool
• Always discuss Lab Sage interpretations with your healthcare provider
• Always seek emergency medical care when appropriate (call 911)

For Healthcare Practitioners

The Practitioner tier of Lab Sage provides clinical decision support information. This information is intended to supplement — not replace — the clinical judgment of the treating healthcare professional. The practitioner:

• Retains sole responsibility for all clinical decisions
• Must independently evaluate all clinical information
• Must exercise independent clinical judgment
• Is responsible for obtaining informed consent from patients
• Must comply with all applicable laws, regulations, and professional standards
• Should not primarily rely on Lab Sage recommendations without independent verification

No Warranty

Lab Sage is provided "as is" and "as available" without any warranties of any kind, whether express, implied, or statutory. We do not warrant that the Service will be accurate, complete, reliable, error-free, or uninterrupted. We make no representations regarding the suitability, reliability, availability, or accuracy of the Service for any purpose.

Assumption of Risk

By using Lab Sage, you expressly acknowledge that you understand and accept all risks associated with using an AI-powered health information tool. You agree that Lab Sage is not responsible for any health outcomes, decisions, or actions taken based on information provided by the Service. Your use of the Service is entirely at your own risk.

Third-Party Information

Lab Sage may reference third-party research, clinical guidelines, or educational resources. We do not endorse or guarantee the accuracy of any third-party content. Links to external resources are provided for educational purposes only.

Contact

If you have questions about this disclaimer or the Service:

• Email: legal@labsage.ai
• Website: https://labsage.ai