FDA product code QKF: Immunocytochemistry Assay, P16/Ki-67
QKF is the FDA product code for immunocytochemistry assay, p16/ki-67. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under QKF reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician.
Classification
| Field | Value |
|---|---|
| Device name | Immunocytochemistry Assay, P16/Ki-67 |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for QKF devices
openFDA lists no recalls for product code QKF.
Frequently asked questions
What is FDA product code QKF?
QKF is the FDA product code for immunocytochemistry assay, p16/ki-67. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is QKF?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QKF
- Run a recall and safety report across every QKF manufacturer
- Watch product code QKF 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 Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times