FDA product code QDS: Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
QDS is the FDA product code for mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.4001 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QDS, 2 in the last five years, from 2 different applicants. The average 510(k) review took 90 days (median 59); 30 days on average over the last three years. FDA has posted 5 recalls for QDS devices, 4 initiated in the last five years.
Definition
A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities.
Classification
| Field | Value |
|---|---|
| Device name | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.4001 |
| Review panel | MI — Microbiology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
510(k) clearances per year for QDS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 181 |
| 2022 | 1 | 59 |
| 2024 | 1 | 30 |
Compare with all 510(k) review times · Search every QDS clearance
Top QDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, LLC | 2 | 2022-10-27 |
| Biofire Diagnostics, LLC (Biomerieux) | 1 | 2024-11-06 |
Most recent QDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243222 | Biofire Diagnostics, LLC (Biomerieux) | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | 2024-11-06 | 30 |
| K222601 | Biofire Diagnostics, LLC | FilmArray Pneumonia Panel plus | 2022-10-27 | 59 |
| K181324 | Biofire Diagnostics, LLC | FilmArray Pneumonia Panel plus | 2018-11-15 | 181 |
Recalls for QDS devices
5 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-02-27.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code QDS?
QDS is the FDA product code for mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.4001 and reviewed by the Microbiology panel.
What device class is QDS?
Class II, regulation 21 CFR 866.4001. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDS?
Across 3 cleared submissions the average was 90 days from receipt to decision (median 59).
Which companies have the most QDS clearances?
Biofire Diagnostics, LLC (2); Biofire Diagnostics, LLC (Biomerieux) (1).
Have QDS devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2025-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code QDS
- Run a recall and safety report across every QDS manufacturer
- Watch product code QDS 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times