FDA product code NKF: Immunohistochemistry Antibody Assay, C-Kit
NKF is the FDA product code for immunohistochemistry antibody assay, c-kit. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under NKF reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for NKF devices.
Definition
Identification/Intended Use - The anti-c-KIT primary antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or manual assay. It is indicated as an aid in the selection of GIST patients who may qualify for imatinib mesylate therapy within the context of the patient's clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. The test is not intended as the sole basis for making the diagnosis of GIST and is not intended as the sole basis for selecting imatinib mesylate therapy. A negative result would not necessarily exclude the diagnosis of GIST
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Antibody Assay, C-Kit |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for NKF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-04-04.
Frequently asked questions
What is FDA product code NKF?
NKF is the FDA product code for immunohistochemistry antibody assay, c-kit. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NKF?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Have NKF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-04-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NKF
- Run a recall and safety report across every NKF manufacturer
- Watch product code NKF 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