(273 days)
Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.
Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices.
The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.
The provided text is a 510(k) Premarket Notification summary for a Viral Transport Medium (VTM), a Class I device. It describes the design, intended use, and studies conducted to demonstrate its substantial equivalence to a predicate device.
It's important to note that this document is not for an AI/ML-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria (such as MRMC studies, ground truth establishment by experts, and training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the device's performance studies and acceptance criteria as provided for this specific product, which focuses on viral recovery performance and shelf-life stability.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance for Viral Transport Medium (VTM)
The studies presented focus on demonstrating the VTM's ability to preserve viral agents over time and under various storage conditions.
1. Table of Acceptance Criteria and Reported Device Performance
For Viral Recovery Performance:
| Acceptance Criteria | Reported Device Performance (20-25°C storage) | Reported Device Performance (2-8°C storage) |
|---|---|---|
| Average viral recovery for each time point and storage condition demonstrates any percent changes within ±90% (i.e., 1 log change) from baseline (T=0). | Influenza A: | |
| 24 hrs: -92.24%* (Accepted as 48h was |
§ 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).