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Pathway Anti-C-Kit (9.7) Rabbit Monoclonal Primary Antibody

FDA PMA

Class III (US FDA PMA)

PMA P020055

by Ventana Medical Systems, Inc.

Identity

Trade Name
VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY FDA PMA
Generic Name
Immunohistochemistry antibody assay, c-kit FDA PMA

Identifiers

PMA Number
P020055 FDA PMA
FDA Product Code
NKF FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 864.1860 FDA PMA
Regulation Number
864.1860 FDA PMA
Advisory Committee
Pathology FDA PMA
FDA Decision
APPR Approved FDA PMA

This device is an immunohistochemistry antibody assay for the qualitative detection of c-Kit protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs). It functions as a primary monoclonal antibody, designed to bind specifically to the c-Kit protein, aiding in the microscopic identification of GISTs under a light microscope.

The Pathway Anti-C-Kit (9.7) Rabbit Monoclonal Primary Antibody is intended for laboratory use with either automated immunohistochemistry staining systems or manual assays. It is supplied as a reagent optimized for use on Ventana Automated Slide Stainers or manually with Ventana’s iView DAB Detection Kit and accessories. The device is classified as a Class III medical device under FDA regulations (PMA P020055) and requires qualified pathologist interpretation within the context of clinical history and other diagnostic tests.

Frequently asked questions

What is the primary use of the Pathway Anti-C-Kit (9.7) Rabbit Monoclonal Primary Antibody in clinical diagnostics?

This antibody is designed for **qualitative detection of c-Kit protein** in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) via immunohistochemistry. It aids pathologists in identifying GISTs under a light microscope and may assist in selecting patients for imatinib mesylate (Gleevec) therapy when used alongside clinical history and other diagnostic tests.

Can this antibody be used with automated systems, or is it only for manual staining?

The Pathway Anti-C-Kit (9.7) antibody is **optimized for both automated and manual use**. It is explicitly validated for Ventana Automated Slide Stainers and can also be applied manually in combination with Ventana’s iView DAB Detection Kit and accessories.

Who should interpret the results of this antibody assay, and what context is required?

Results must be interpreted by a **qualified pathologist** within the broader context of the patient’s clinical history, tumor morphology, and other diagnostic tests. The antibody itself only provides qualitative detection of c-Kit protein—interpretation requires correlation with additional diagnostic information.

Is this antibody intended for single-use or can it be reused?

The Pathway Anti-C-Kit (9.7) antibody is supplied as a **reagent for laboratory use**, meaning it is designed for repeated use in staining procedures within a controlled laboratory setting. However, proper storage and handling per manufacturer guidelines are required to maintain efficacy.

What type of tissue samples is this antibody specifically designed to analyze?

This antibody is **intended exclusively for formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs)**. It is not designed for use with fresh tissue, frozen sections, or other types of tumors unless explicitly validated for those applications (which it is not).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Ventana Medical Systems, Inc.

Sources (1)

  • FDA PMA P020055 24 fields · synced Oct 6, 2026