Laboratories evaluating qPCR platforms for food safety testing often encounter “Research Use Only” (RUO) labeling on certain thermocyclers. This designation can raise questions about regulatory compliance when performing microbial testing.
Overview
Laboratories evaluating qPCR platforms for cannabis and food safety testing often encounter “Research Use Only” (RUO) labeling on certain thermocyclers, such as the Bio Molecular Systems (BMS) Mic. This designation can raise questions about regulatory compliance when performing state-mandated microbial testing.
This article clarifies the meaning of the RUO label, explains its relevance (or lack thereof) in cannabis testing, and provides guidance on using PathoSEEK® qPCR assays with the Mic thermocycler in a compliant and future-proof manner.
RUO vs. IVD Labeling — What’s the Difference?
RUO (Research Use Only) labeling is applied to instruments or reagents intended for research or in laboratory development methods, but not human clinical diagnostics.
IVD (In Vitro Diagnostic) products, on the other hand, are cleared or approved by regulatory agencies (such as the FDA) for use in diagnosing human disease.
The RUO/IVD distinction applies only in a clinical diagnostic context — for example, tests performed on human specimens for medical decision-making. Food safety testing is regulated under product quality and environmental testing frameworks, not human health diagnostics.
Therefore, the RUO marking on a thermocycler does not limit its use for food safety compliance or environmental pathogen testing.
Compatibility and Validation
Medicinal Genomics’ PathoSEEK® assays are validated for food safety, environmental, and cannabis testing applications. They are fully compatible with standard programmable 96-well qPCR instruments that include a heated lid, including but limited to:
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Bio Molecular Systems Mic
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Bio-Rad CFX series
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Agilent AriaMx
These combinations have been reviewed and accepted by internal and external auditors under ISO 17025 and AOAC Performance Tested Method (PTM) frameworks. Many licensed laboratories in the U.S. and Canada currently use the these instruments with PathoSEEK assays for microbial testing without issue.
Regulatory Context
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Missouri (19 CSR 100-1.110) for example, and similar state cannabis regulations require validated analytical methods but do not mandate IVD-status instrumentation.
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PathoSEEK® assays meet these requirements through AOAC PTM validation and rigorous internal performance data demonstrating specificity, sensitivity, and linearity.
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FDA Laboratory Developed Test (LDT) regulations and the RUO/IVD framework apply exclusively to human clinical diagnostics, not product safety testing.
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Cannabis remains federally unregulated by the FDA until full rescheduling or de-scheduling occurs. At such time, analytical testing will most likely remain under state-level quality and safety programs, or follow food safety testing frameworks.