(a) Identification. A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.

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

(1) The intended use on the device's label and labeling required under § 809.10 of this chapter must include a detailed description of the type(s) of human specimens intended for collection and preservation, and the characteristics of the microbial population intended for subsequent analysis.

(2) The labeling required under § 809.10(b) of this chapter must include:

(i) A detailed device description, including reagents, ancillary reagents required but not provided, and all other parts that make up the device.

(ii) A warning statement that the device is not for the detection of specific microbial pathogens.

(iii) A warning statement that the device should only be used with legally marketed assays that are indicated for use with the device, including, as appropriate, indicated for the relevant storage and transport conditions.

(iv) Description of the microorganisms used for studies, including the results and performance summaries, required under paragraph (b)(3)(i) of this section.

(3) Design verification and validation must include:

(i) Detailed documentation and results from studies used for device validation. This detailed documentation must include a detailed identification of each of the following (which must be representative of the spectrum of situations in which the device might be used that are within the scope of the device's intended use): the panel of microorganisms, the extraction platforms, the assay protocols used to measure the stabilization of relative ratios (relative abundance) of the microorganisms in the sample, and the bioinformatic pipelines used in the validation studies for the determination of relative abundances of preserved nucleic acids.

(ii) For devices intended for the collection of samples, detailed documentation and results from studies that demonstrate the device's usability, including user collection studies that demonstrate that the user instructions are appropriate for the intended collection methods (e.g., self-collection or clinician/laboratory collection) and users.