FDA product code QTA: Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
QTA is the FDA product code for ngs whole genome sequencing for sars-cov-2 genetic analysis. It is a Not classified device, reviewed by the Microbiology panel. Devices under QTA reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
This is an IVD test which utilizes a next generation sequencing (NGS) method performed on a high throughput sequencing platform. This test can identify and differentiate SARS-CoV-2 and support additional genetic analysis, when clinically indicated, from SARS-CoV-2-positive samples identified as positive using an EUA authorized diagnostic test. Testing is limited to designated laboratories.
Classification
| Field | Value |
|---|---|
| Device name | Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QTA devices
openFDA lists no recalls for product code QTA.
Frequently asked questions
What is FDA product code QTA?
QTA is the FDA product code for ngs whole genome sequencing for sars-cov-2 genetic analysis. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QTA?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QTA
- Run a recall and safety report across every QTA manufacturer
- Watch product code QTA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.