FDA product code QDP: Respiratory Panel
QDP is the FDA product code for respiratory panel. It is a Class II device, regulated under 21 CFR 866.3985 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QDP. The average 510(k) review took 118 days (median 118).
Definition
The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection.
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Panel |
| Device class | Class II |
| Regulation | 21 CFR 866.3985 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QDP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 210 |
| 2021 | 1 | 26 |
Compare with all 510(k) review times · Search every QDP clearance
Top QDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, LLC | 2 | 2021-09-22 |
Most recent QDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212727 | Biofire Diagnostics, LLC | FilmArray Pneumonia Panel | 2021-09-22 | 26 |
| K180966 | Biofire Diagnostics, LLC | FilmArray Pneumonia Panel | 2018-11-09 | 210 |
Recalls for QDP devices
openFDA lists no recalls for product code QDP.
Frequently asked questions
What is FDA product code QDP?
QDP is the FDA product code for respiratory panel. It is a Class II device, regulated under 21 CFR 866.3985 and reviewed by the Microbiology panel.
What device class is QDP?
Class II, regulation 21 CFR 866.3985. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDP?
Across 2 cleared submissions the average was 118 days from receipt to decision (median 118).
Which companies have the most QDP clearances?
Biofire Diagnostics, LLC (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QDP
- Run a recall and safety report across every QDP manufacturer
- Watch product code QDP 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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