(a) Identification. A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. 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 for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.

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

(i) A detailed device description, including all device components;

(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;

(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and

(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.

(3) Design verification and validation must include the following:

(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;

(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and

(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.