FDA product code QKP: Coronavirus Antigen Detection Test System.
QKP is the FDA product code for coronavirus antigen detection test system.. It is a Not classified device, reviewed by the Microbiology panel. Devices under QKP reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 47 recalls for QKP devices, 27 initiated in the last five years.
Definition
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Classification
| Field | Value |
|---|---|
| Device name | Coronavirus Antigen Detection Test System. |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QKP devices
47 product recalls in 37 recall events; 27 initiated in the last five years and 23 still open. Most recent: 2025-01-24.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 25 |
| 2022 | 18 |
| 2023 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code QKP?
QKP is the FDA product code for coronavirus antigen detection test system.. It is a Not classified device, reviewed by the Microbiology panel.
What device class is QKP?
Not classified. Typical premarket route: PMA.
Have QKP devices been recalled?
Yes: 47 product recalls across 37 recall events; the most recent began 2025-01-24.
Next steps
- Run an FDA pathway report with predicate devices for product code QKP
- Run a recall and safety report across every QKP manufacturer
- Watch product code QKP 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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