FDA product code QLT: Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
QLT is the FDA product code for covid-19 multi-analyte respiratory panel nucleic acid devices. It is a Not classified device, reviewed by the Microbiology panel. Devices under QLT reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 11 recalls for QLT devices, 9 initiated in the last five years.
Definition
Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
Classification
| Field | Value |
|---|---|
| Device name | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLT devices
11 product recalls in 8 recall events; 9 initiated in the last five years and 8 still open. Most recent: 2024-09-05.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 4 |
| 2023 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code QLT?
QLT is the FDA product code for covid-19 multi-analyte respiratory panel nucleic acid devices. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QLT?
Not classified. Typical premarket route: PMA.
Have QLT devices been recalled?
Yes: 11 product recalls across 8 recall events; the most recent began 2024-09-05.
Next steps
- Run an FDA pathway report with predicate devices for product code QLT
- Run a recall and safety report across every QLT manufacturer
- Watch product code QLT 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.
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