| 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 | PD-L1 IHC 28-8 pharmDx |
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| Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
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| Applicant | Agilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051 |
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| PMA Number | P150025 |
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| Supplement Number | S018 |
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| Date Received | 01/02/2026 |
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| Decision Date | 07/01/2026 |
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| Product Code |
PLS |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT02872116
|
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| Supplement Type | Panel 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
Approval for the PD-L1 IHC 28-8 pharmDx for expanding the indications to include use as an aid in identifying patients with esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma for treatment with OPDIVO (nivolumab) or OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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