Product Classification

• Device: immunohistochemistry antibody assay, c-kit
• Regulation Description: Immunohistochemistry reagents and kits.
• 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
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Product Code: NKF
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: PMA
• Regulation Number: 864.1860
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-219 CLSI I/LA28-A2
  Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.

Third Party Review

Not Third Party Eligible