| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MAGE-A4 IHC 1F9 pharmDx |
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| Generic Name | Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 |
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| Regulation Number | 864.1860 |
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| Applicant | AGILENT TECHNOLOGIES, INC.
6392 Via Real
Carpinteria, CA 93013 |
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| PMA Number | P230016 |
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| Date Received | 05/01/2023 |
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| Decision Date | 08/01/2024 |
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| Product Code |
SBL |
| Docket Number | 24M-5449 |
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| Notice Date | 11/27/2024 |
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| Advisory Committee |
Pathology |
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| Clinical Trials | NCT04044768
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 |
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