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510(k) Data Aggregation

    K Number
    K260787

    Validate with FDA (Live)

    Device Name
    FebriDx Bacterial/Non-bacterial Assay
    Manufacturer
    Lumos Diagnostics, Inc.
    Date Cleared
    2026-03-24

    (14 days)

    Product Code
    QXA
    Regulation Number
    866.3230
    Type
    Dual Track
    Panel
    Microbiology
    Age Range
    1 - 64
    Reference & Predicate Devices
    K230917
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FebriDx Bacterial/Non-bacterial Assay is a qualitative visually read rapid immunoassay for the detection of human host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from fingerstick blood. FebriDx is indicated for use in patients aged 12-64 for evaluation of acute respiratory infection who have had symptoms for less than 7 days and within 3 days of fever onset.

    FebriDx test results are intended to be used in conjunction with other clinical and diagnostic findings as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology. The assessment of whether a bacterial infection is present should always be based on consideration of all available information, and not based solely on the FebriDx test results. FebriDx test results are not intended to identify a specific pathogen or the severity of infection.

    FebriDx External Controls:
    FebriDx External Controls are used in the FebriDx Test as assayed quality control samples to assess the performance and reliability of the FebriDx Test.

    Special conditions for use statement(s):

    • For in vitro diagnostic use
    • For prescription use only
    Device Description

    FebriDx Test:
    FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood to aid in the evaluation of acute respiratory infections. The single-use, disposable FebriDx test is an all-in-one integrated platform that includes a lateral flow test strip, a built-in retractable safety lancet, blood collection and transfer tube and buffer delivery system. The FebriDx test produces a visual-read qualitative result. Operators interpret the test and can visually see whether the infection may be due to a bacterial infection or other non-bacterial etiology.

    FebriDx External Controls:
    FebriDx External Controls to monitor performance and reliability of the FebriDx test are sold separately. FebriDx External Controls are a two-vial set with one negative buffer and one positive control containing recombinant CRP and MxA.

    AI/ML Overview

    N/A

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