| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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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| Supplement Number | S003 |
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| Date Received | 05/28/2026 |
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| Decision Date | 09/15/2026 |
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| Product Code |
SBL |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT04044768
|
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
MAGE-A4 IHC IF9 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 tissue 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 patients with synovial sarcoma for whom TECELRA® (afamitresgene autoleucel), a MAGE-A4-directed genetically modified autologous T-cell immunotherapy, is being considered. |
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