(a) Identification. This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The test must use a sample collection device that is FDA-cleared, -approved, or -classified as 510(k) exempt with an indication for over-the-counter in vitro diagnostic use in molecular testing; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device in which performance data demonstrate that lay users can correctly collect specimens without health care provider (HCP) supervision.

(2) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: the analytes the device detects and identifies, the clinical indications for which the test is to be used, the specimen types tested, the specific intended population(s), the name of the testing facility or facilities, as applicable, and other conditions of use as appropriate.

(3) The intended use of the device must only include indications for testing of specimens that are appropriate for collection by lay users for which there are performance data that demonstrate lay users can correctly collect specimens without HCP supervision.

(4) Design verification and validation must include:

(i) A detailed test description of test components, including reagents, instruments, ancillary materials, control elements, and a detailed explanation of the methodology, including pre-analytical methods for processing of specimens, microorganism target(s), identification of target detection reagents (e.g., primers), internal controls, and computational path from collected raw data to reported results (e.g., how collected raw signals are converted into a reported signal and result), as applicable to the detection method and device design.

(ii) A description of the process from acquisition of the collection kit to results reporting.

(iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing.

(iv) Detailed documentation and test performance results from a clinical study that includes prospective self-collected samples for each claimed specimen type. This study must be performed on a study population consistent with the intended use population and compare the device's performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation from the clinical study must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of statistical analyses.

(v) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as failure modes and effects analysis and/or hazard analysis. This must include information that demonstrates the effectiveness of risk control measures and device robustness, including the entire testing procedure from sampling to result interpretation, based on results from the following studies, as applicable per the intended use of the test device: usability studies, user label comprehension studies, and flex studies.

(vi) Detailed documentation of analytical studies, including the limit of detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross-contamination, specimen stability, within-lab precision, and reproducibility, as applicable.

(vii) Validation data to support specimen integrity during handling and shipping.

(viii) Detailed documentation of reagent stability studies.

(ix) For devices with associated software or instrumentation, a detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, hazard analysis, and risk assessment activities.

(5) The labeling required under § 809.10(b) of this chapter must include the following:

(i) Clear information written in appropriate language for the intended user that includes: instructions for sample collection and sample packaging for shipping and transport to the testing site; an explanation of test results and results interpretation, including instructions on what actions to take based on the test results; and information for technical assistance with the collection kit.

(ii) A frequently asked questions section that provides technical and educational information (e.g., information about notifying sexual partners, how to prevent future infections, what to do if symptoms persist after treatment, directions to resources for further information on the disease and epidemiology).

(iii) Warning and limitation statements, including the following:

(A) A negative test result does not preclude the possibility of infection with other pathogens;

(B) The test system is not a substitute for visits to a healthcare provider. The information provided by the product should not be used to start, stop, or change any course of treatment unless advised by the healthcare provider;

(C) Anyone with recent sexual contact with a person known to have a sexually transmitted infection should visit a healthcare provider for treatment and evaluation as soon as possible (refer to professional guidelines);

(D) Contact a healthcare provider prior to collecting the sample if the user has a condition that makes it difficult to use the test (e.g., problems with vision, handling the test components, or understanding test instructions or results);

(E) Accurate results are dependent on adequate product storage and adherence to the specimen collection and testing procedures;

(F) Failure to follow test procedures can lead to incorrect results; and

(G) The home collection kit must not be used beyond the expiration date. Use of expired kits can lead to incorrect results.

(iv) Accessioning criteria for acceptability of samples received by the laboratory (e.g., time from sample collection, transport media leakage, integrity of the sample).

(6) The device's labeling must include a prominent hyperlink to the manufacturer's public website where the manufacturer must make the information identified in this section publicly and prominently available. The information must include, written in language appropriate for the intended user:

(i) A brief summary of the purpose of the test.

(ii) Detailed instructions for proper sample collection and shipping procedures, and interpretation of results.

(iii) Required warnings and limitation statements.

(iv) Contact information for technical assistance with the collection kit (e.g., helpline contact information).

(v) For tests intended for over-the-counter use, information on who should and who should not use this test, and directions for further information for a user who might not be appropriate for testing using this device.

(vi) For tests intended for over-the-counter use, information for users on any follow-up actions (e.g., a link for in-person consultation or telehealth visit with an HCP).

(vii) The performance characteristics established in required studies.

(viii) If appropriate (e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed research, as determined by FDA), information that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type.

(ix) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that:

(A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present;

(B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora;

(C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and

(D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acids may persist following appropriate antimicrobial therapy.

(7) The outer box label required under § 809.10(a) of this chapter must include the following:

(i) A description of who may use the home collection kit and age of the intended users.

(ii) A list of the components included.

(iii) A list of the components required, but not provided (e.g., software applications needed to complete the process).

(iv) A statement that this is a home sample collection kit which requires shipping of the sample to a laboratory within the specified timeframe to receive results.

(v) A statement that anyone with recent sexual contact with a person known to have a sexually transmitted infection should visit a healthcare provider for treatment and evaluation as soon as possible (refer to professional guidelines).