Search Results

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:

1. Inactivate target viruses rapidly.
2. Preserve the nucleic acids of the target viruses over a specified period and temperatures (stability).
3. Detect the target viruses at a low concentration (Limit of Detection - LoD).

Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device