BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FebriDx Bacterial/Non-bacterial Assay

    K Number: K260787 · Decision Mar 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    14

    Basic Information

    Device Name
    FebriDx Bacterial/Non-bacterial Assay
    K Number
    K260787
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3230
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lumos Diagnostics, Inc.
    Date Received
    March 10, 2026
    Decision Date
    March 24, 2026
    Product Code
    QXA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QXA), ordered by most recent decision date.

    FebriDx Bacterial / Non-bacterial Point of Care Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology
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    Other Clearances by Lumos Diagnostics, Inc.

    K Number Device Name
    K230917 FebriDx Bacterial / Non-bacterial Point of Care Assay