NKF — Immunohistochemistry Antibody Assay, C-Kit Class III
FDA product code NKF covers "Immunohistochemistry Antibody Assay, C-Kit", a Class III medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- NKF
- Device Class
- Class III
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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