FDA product code QPS: Immunoassay For Host Biomarkers Of Infection
QPS is the FDA product code for immunoassay for host biomarkers of infection. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under QPS, 3 in the last five years, from 2 different applicants. The average 510(k) review took 186 days (median 212).
Definition
A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay For Host Biomarkers Of Infection |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QPS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 215 |
| 2022 | 1 | 210 |
| 2023 | 2 | 160 |
Compare with all 510(k) review times · Search every QPS clearance
Top QPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| MeMed Diagnostics, Ltd. | 3 | 2023-06-30 |
| DiaSorin, Inc. | 1 | 2022-07-14 |
Most recent QPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230944 | MeMed Diagnostics, Ltd. | MeMed BV | 2023-06-30 | 87 |
| K222332 | MeMed Diagnostics, Ltd. | MeMed BV | 2023-03-23 | 233 |
| K213936 | DiaSorin, Inc. | LIAISON MeMed BV, LIAISON MeMed BV Control Set | 2022-07-14 | 210 |
| K210254 | MeMed Diagnostics, Ltd. | MeMed BV | 2021-09-01 | 215 |
Recalls for QPS devices
openFDA lists no recalls for product code QPS.
Frequently asked questions
What is FDA product code QPS?
QPS is the FDA product code for immunoassay for host biomarkers of infection. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is QPS?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPS?
Across 4 cleared submissions the average was 186 days from receipt to decision (median 212).
Which companies have the most QPS clearances?
MeMed Diagnostics, Ltd. (3); DiaSorin, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPS
- Run a recall and safety report across every QPS manufacturer
- Watch product code QPS 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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