Identity
- Trade Name
- VENTANA ALK (D5F3) CDX ASSAY FDA PMA
- Generic Name
- Immunohistochemistry assay, antibody, anaplastic lymphoma kinase FDA PMA
Identifiers
- PMA Number
- P140025 FDA PMA
- FDA Product Code
- PKW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Ventana ALK (D5F3) CDX Assay is an immunohistochemistry assay designed for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue. It employs a monoclonal antibody (clone D5F3) to identify ALK protein expression, aiding in patient stratification for targeted therapy.
This assay is intended for use on the Ventana BenchMark XT automated staining instrument and is supplied as a diagnostic reagent. It is classified as a Class III device under FDA regulations and requires a PMA approval (P140025). The assay is not sterile and is intended for single-use in a pathology laboratory setting, with no specific MRI safety considerations. Storage and handling must comply with standard FFPE tissue processing protocols.
Frequently asked questions
What is the purpose of the Ventana ALK (D5F3) CDX Assay?
The Ventana ALK (D5F3) CDX Assay is an immunohistochemistry assay designed for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma tissue. It aids in identifying patients eligible for treatment with XALKORI (crizotinib).
How is the Ventana ALK (D5F3) CDX Assay supplied?
The assay is supplied as a diagnostic reagent and is intended for use on the Ventana BenchMark XT automated staining instrument. It is classified as a Class III device under FDA regulations and requires PMA approval (P140025).
Is the Ventana ALK (D5F3) CDX Assay sterile and can it be reused?
The assay is not sterile and is intended for single-use in a pathology laboratory setting. It should not be reused and must be handled according to standard laboratory protocols.
What are the storage requirements for the Ventana ALK (D5F3) CDX Assay?
Storage and handling must comply with standard FFPE tissue processing protocols. Specific temperature and environmental conditions should be followed as per the manufacturer's instructions to maintain assay integrity.
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. Sources consulted: Home | Ventana
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P140025 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P140025 24 fields · synced Oct 6, 2026