Regulatory Guidlines

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Mass Spec Technologies products, including our AI-powered Laboratory Information System (LIS), next-generation PCR machines, and associated software and analysis algorithms, are provided for Research Use Only (RUO).

Not for use in diagnostic procedures.These systems and any outputs generated (including amplification curve interpretations, confidence scores, result calls, or predictive analytics) have not been reviewed, cleared, or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for clinical diagnostic use, patient management decisions, or reporting of results intended for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.

Our technologies are intended solely for research applications in qualified laboratories. Use of these products for any clinical, diagnostic, or therapeutic purpose is strictly prohibited and may violate applicable regulations, including but not limited to the Federal Food, Drug, and Cosmetic Act (FD&C 

Act) and CLIA requirements when performed for patient testing.

HIPAA Compliance & Data PrivacyMass Spec Technologies is fully committed to protecting patient privacy and safeguarding protected health information (PHI). Our cloud-based LIS and data-handling infrastructure are designed and operated in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and the HITECH Act. This includes:

• End-to-end encryption of data in transit and at rest
• Robust access controls, audit logging, and role-based permissions
• Business Associate Agreements (BAAs) available for covered entities
• Regular third-party security assessments and penetration testing
• Secure, anonymized handling of any training data used for model refinement

Only de-identified or consented research data is utilized for continuous AI improvement.

Commitment to Best Practices & Quality StandardsWhile our products are offered for RUO, Mass Spec Technologies adheres to the highest standards of design, manufacturing, software development, and laboratory practice, including:

• ISO 13485-aligned quality management systems (where applicable to RUO development processes)
• Rigorous internal validation and verification protocols
• Traceable documentation and change control
• Continuous monitoring of system performance and cybersecurity
• Compliance with applicable CLIA, CAP, and state laboratory regulations when our tools are used in supporting research within certified environments

We strongly recommend that laboratories consult their institutional review boards (IRBs), legal counsel, and regulatory experts before integrating any RUO instrumentation or software into workflows that may impact human subject research or future clinical validation pathways.

Mass Spec Technologies makes no representations or warranties, express or implied, that these products are suitable for any purpose beyond research use. Users assume all responsibility and liability for the appropriate application of these technologies in accordance with applicable laws and regulations.

For questions regarding regulatory status, intended use, or compliance documentation, please contact our regulatory affairs team at compliance@massspec-technologies.com.

Last updated: January 2026