(389 days)
The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).
The Disposable Sampler Viral Transport Media is composed of preservation tubes filled with VTM (Viral Transport Media), kitted with or without swabs, depending on the product type. The Disposable Sampler Viral Transport Media is composed of Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Magnesium sulfate heptahydrate, Glucose, HEPES, Sodium bicarbonate, Fluconazole, Gentamicin sulfate, Griseofulvin, Polymyxin sulfate, Phenol red (optional), Sodium hydroxide, Calcium chloride, Bovine serum albumin and L-Cysteine. The preservation tube is made of medical-grade polypropylene materials. 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 document describes a 510(k) premarket notification for the "Disposable Sampler Viral Transport Media" by Wuxi NEST Biotechnology Co., Ltd. The study conducted is a non-clinical performance test focusing on culture-based viral recovery.
Here's an analysis of the provided information according to your requested components:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Recovery (Implicit) | The NEST Disposable Samplers "preserved the samples of all the viruses tested for up to 48 hours at both room temperature and when refrigerated." The results "confirm that the media stabilizes the target viruses meeting the performance specifications for the subject device." No specific quantitative threshold (e.g., maximum attenuation rate) is explicitly stated as an "acceptance criterion" but the performance data (Table 2) shows varying attenuation rates for different viruses, temperatures, and timepoints, all of which are presented as acceptable evidence of performance. |
*Note: The document states the device "meets the performance specifications," but does not explicitly list what those specifications are in a quantitative manner (e.g., "attenuation rate must be
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).