Home collection within a laboratory testing system
FDA’s final amendment and final order, published and effective on 9 October 2026, adds 21 CFR 866.3385. It codifies the Class II classification applicable from 15 November 2023 for systems detecting nucleic acids from non-viral microorganisms causing sexually transmitted infections using home-collected specimens.
The generic system is intended for self-collection at home or in similar environments, followed by testing in a clinical laboratory to aid STI diagnosis. It may be intended for prescription or over-the-counter use. The category does not describe a consumer performing the assay and obtaining results at home, and its scope should not be expanded to all STI pathogens.
The system remains subject to 510(k). A collection component’s exemption status does not confer exemption on the entire testing system. Prescription systems also remain subject to the applicable IVD prescription labelling provisions.
Collection and each claimed specimen need support
The rule permits use of a collection device that is FDA-cleared, approved, or classified as 510(k)-exempt with an indication for OTC IVD molecular testing. Alternatively, the collection device must be cleared as part of the system’s premarket submission, with performance data demonstrating correct collection by lay users without healthcare provider supervision. Claimed specimens must be appropriate for lay collection and supported by such performance data.
Clinical validation must include prospectively self-collected samples for every claimed specimen type, in a population consistent with intended use, and comparison against an FDA-appropriate comparator. Documentation includes the protocol with a predefined statistical analysis plan, study report, test results and statistical analyses. Evidence for one specimen type should not be assumed to support another.
Verification and validation must describe the process from acquisition of the kit to result reporting, the methodology and pre-analytical processing, interpretation and quality control acceptance criteria. The rule also requires evidence supporting specimen integrity during handling and shipping. Analytical studies, usability studies, label comprehension and flex studies apply according to the system’s intended use and design.
Labelling must state accessioning criteria for samples received by the laboratory. The outer box must explain that the product is a home sample collection kit requiring shipment to a laboratory within a specified timeframe to obtain results. These provisions connect the consumer-facing description to the workflow supported by validation.
Result interpretation and follow-up are part of the system
User information must explain collection, packaging and transport, result interpretation, actions based on results and technical support. A frequently asked questions section must provide technical and educational information, including relevant information on partner notification, prevention and persistent symptoms. A prominent labelling hyperlink must direct users to publicly and prominently available manufacturer information. OTC systems must also explain appropriate and inappropriate users and follow-up options.
Required warnings include that a negative result does not exclude infection with other pathogens and that the system does not replace a healthcare visit. Users should not start, stop or alter treatment without healthcare provider advice. Recent sexual contact with a person known to have an STI calls for prompt healthcare evaluation and treatment. Storage, procedural adherence and kit expiry also affect the reliability of results.
Systems claiming antimicrobial resistance marker detection require additional limiting statements where appropriate. A negative marker result does not establish susceptibility; detected markers cannot be definitively attributed to a specific microorganism and may not correlate with phenotypic expression. Assay results cannot determine treatment success or failure, including because nucleic acids may persist after appropriate therapy.
For developers, the central assessment covers the complete system: who collects which specimen, how it is shipped and accepted, where it is tested, and how results are understood. Convenience claims should remain within that validated workflow.