FDA product code QGN: Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
QGN is the FDA product code for lateral flow immunochromatography assay for host infection biomarkers. It is a Class II device, regulated under 21 CFR 866.3230 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QGN. The average 510(k) review took 27 days (median 27). 1 De Novo request was granted under it.
Definition
A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Lateral Flow Immunochromatography Assay For Host Infection Biomarkers |
| Device class | Class II |
| Regulation | 21 CFR 866.3230 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QGN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 27 |
Compare with all 510(k) review times · Search every QGN clearance
Top QGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cd Diagnostics, Inc. | 1 | 2021-08-11 |
Most recent QGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212204 | Cd Diagnostics, Inc. | Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | 2021-08-11 | 27 |
Recalls for QGN devices
openFDA lists no recalls for product code QGN.
Frequently asked questions
What is FDA product code QGN?
QGN is the FDA product code for lateral flow immunochromatography assay for host infection biomarkers. It is a Class II device, regulated under 21 CFR 866.3230 and reviewed by the Microbiology panel.
What device class is QGN?
Class II, regulation 21 CFR 866.3230. Typical premarket route: 510(k).
How long does a 510(k) take for product code QGN?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most QGN clearances?
Cd Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGN
- Run a recall and safety report across every QGN manufacturer
- Watch product code QGN 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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