Product code NKF

Device name

Immunohistochemistry Antibody Assay, C-Kit

Medical specialty

Hematology

Device class

3

Regulation number

864.1860

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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

Source

FDA openFDA device classification dataset