BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P150013 · Supplement: S031 · Decision Mar 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
    Trade Name
    PD-L1 IHC 22C3 pharmDx
    PMA Number
    P150013
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    PLS
    Generic Name
    Immunohistochemistry assay, antibody, programmed death-ligand 1
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 19, 2026
    Date Received
    July 28, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to migrate the PD-L1 IHC 22C3 pharmDx assay using the Autostainer Link 48 for esophageal squamous cell carcinoma (ESCC) with CPS>=10, triple-negative breast cancer (TNBC) with CPS>=10, cervical cancer with CPS>=1, and gastric or gastroesophageal junction (GEJ) adenocarcinoma with CPS>=1 indication to the Dako Omnis automated staining system.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1