(220 days)
NEST ITM is an enclosed system intended for the collection, inactivation stabilization and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from the collection site to the testing laboratory. The specimen transported in NEST ITM can be used for molecular detection in the laboratory.
The NEST ITM is a medical-grade Polypropylene preservation tube (5 mL and 10 mL) filled with 2.5 mL ITM Inactivated Transport Media for 5 mL tube or 3 mL Inactive Transport Media for 10 mL tube, with or without the sterile swabs. NEST ITM is composed of Guanidine isothiocyanate, TCEP, sodium acetate, PEG-6000, Tris, Hcl, purified water in order to inactivate infectious unprocessed oropharyngeal and nasopharyngeal samples which are suspected of containing adenovirus, influenza A virus or parainfluenza virus 2 from human samples. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).
The provided text describes the non-clinical performance data for the "Disposable Sampler Inactivated Transport Media (NEST ITM)". This device is a microbial nucleic acid storage and stabilization device, not an AI/ML-based device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., human-in-the-loop, MRMC studies, ground truth establishment for deep learning models) are not applicable.
However, I can extract information related to the device's functional performance, which serves as its "acceptance criteria" for demonstrating substantial equivalence to a predicate device.
Here's the relevant information:
Device: Disposable Sampler Inactivated Transport Media (NEST ITM)
Purpose: Collection, inactivation, stabilization, and transportation of pharyngeal and nasal swabs suspected of containing adenovirus, influenza A virus, or parainfluenza virus 2 for molecular detection.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are its ability to:
- Inactivate target viruses rapidly.
- Preserve the nucleic acids of the target viruses over a specified period and temperatures (stability).
- Detect the target viruses at a low concentration (Limit of Detection - LoD).
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Internal/Implicit) | Reported Device Performance |
|---|---|---|
| Inactivation | >4.0 log reduction in viral concentration (similar to predicate) within 10 seconds. Absence of viral cytopathic effect (CPE) at specific dilutions. | Rapidly inactivated all tested viruses (Adenovirus, Influenza A, Parainfluenza 2 virus) with >4.0 log reduction at a 1:10 specimen to media concentration at 10 seconds. Viral CPE could not be observed at |
§ 866.2950 Microbial nucleic acid storage and stabilization device.
(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.