FDA product code PKW: Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
PKW is the FDA product code for immunohistochemistry assay, antibody, anaplastic lymphoma kinase. It is a Class III device, reviewed by the Pathology panel. Devices under PKW reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PKW devices
openFDA lists no recalls for product code PKW.
Frequently asked questions
What is FDA product code PKW?
PKW is the FDA product code for immunohistochemistry assay, antibody, anaplastic lymphoma kinase. It is a Class III device, reviewed by the Pathology panel.
What device class is PKW?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PKW
- Run a recall and safety report across every PKW manufacturer
- Watch product code PKW 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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