Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
Basic Information
- Device Name
- Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
- Trade Name
- MAGE-A4 IHC 1F9 pharmDx
- PMA Number
- P230016
- Device Class
- FDA Class 3
- Product Code
- SBL
- Generic Name
- Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 1, 2024
- Date Received
- May 1, 2023
- Expedited Review
- N
- Docket Number
- 24M-5449
Advisory Committee Statement
MAGE-A4 IHC 1F9 pharmDx is a qualitative immunohistochemical (IHC) assay using monoclonal mouse anti-MAGE-A4, Clone OTI1F9, intended for use in the detection of MAGE-A4 protein in formalin-fixed, paraffin-embedded (FFPE) synovial sarcoma tissues using the EnVision FLEX visualization system on Autostainer Link 48. MAGE-A4 protein expression in synovial sarcoma is determined by using the MAGE-A4 Tumor Intensity Proportion Score (TIPS), which is the overall percentage of viable tumor cells showing MAGE-A4 nuclear and/or cytoplasmic staining at staining intensity ? 2+. The specimen should be considered positive if MAGE-A4 TIPS (? 2+) is ? 75%.MAGE-A4 IHC 1F9 pharmDx is indicated as an aid in identifying adult patients with synovial sarcoma for whom TECELRA® (afamitresgene autoleucel), a MAGE-A4 directed genetically modified autologous T- cell immunotherapy is being considered.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SBL | Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 | FDA class 3 | Hematology |