FDA product code QXA: Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
QXA is the FDA product code for lateral flow immunochromatography assay for host biomarkers of respiratory infection. It is a Class II device, regulated under 21 CFR 866.3230 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QXA, 2 in the last five years. The average 510(k) review took 51 days (median 51); 14 days on average over the last three years.
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 Biomarkers Of Respiratory Infection |
| 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 QXA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 88 |
| 2026 | 1 | 14 |
Compare with all 510(k) review times · Search every QXA clearance
Top QXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lumos Diagnostics, Inc. | 2 | 2026-03-24 |
Most recent QXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260787 | Lumos Diagnostics, Inc. | FebriDx Bacterial/Non-bacterial Assay | 2026-03-24 | 14 |
| K230917 | Lumos Diagnostics, Inc. | FebriDx Bacterial / Non-bacterial Point of Care Assay | 2023-06-30 | 88 |
Recalls for QXA devices
openFDA lists no recalls for product code QXA.
Frequently asked questions
What is FDA product code QXA?
QXA is the FDA product code for lateral flow immunochromatography assay for host biomarkers of respiratory infection. It is a Class II device, regulated under 21 CFR 866.3230 and reviewed by the Microbiology panel.
What device class is QXA?
Class II, regulation 21 CFR 866.3230. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXA?
Across 2 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most QXA clearances?
Lumos Diagnostics, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QXA
- Run a recall and safety report across every QXA manufacturer
- Watch product code QXA 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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