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510(k) Data Aggregation

    K Number
    K250358
    Device Name
    BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-10-31

    (266 days)

    Product Code
    PCI,OOI,PCH
    Regulation Number
    866.3990
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252387
    Device Name
    Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
    Manufacturer
    Diasorin Molecular, LLC
    Date Cleared
    2025-10-30

    (91 days)

    Product Code
    QOF
    Regulation Number
    866.3981
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251875
    Device Name
    LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
    Manufacturer
    Affinity Biosensors, LLC
    Date Cleared
    2025-10-27

    (131 days)

    Product Code
    SAN
    Regulation Number
    866.1650
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251289
    Device Name
    WELLlife COVID-19 Antigen Test Rx
    Manufacturer
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Cleared
    2025-10-22

    (180 days)

    Product Code
    QVF
    Regulation Number
    866.3982
    Type
    Dual Track
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252329
    Device Name
    QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
    Manufacturer
    QIAGEN GmbH
    Date Cleared
    2025-10-22

    (89 days)

    Product Code
    PCH
    Regulation Number
    866.3990
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K251749
    Device Name
    Flowflex Plus RSV + Flu A/B + COVID Home Test
    Manufacturer
    ACON Laboratories, Inc.
    Date Cleared
    2025-10-22

    (138 days)

    Product Code
    SCA
    Regulation Number
    866.3987
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251595
    Device Name
    COVID-19 Detect Rapid Self -Test
    Manufacturer
    InBios International, Inc.
    Date Cleared
    2025-10-12

    (138 days)

    Product Code
    QYT
    Regulation Number
    866.3984
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250249
    Device Name
    Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
    Manufacturer
    Gold Standard Diagnostics, LLC.
    Date Cleared
    2025-10-10

    (256 days)

    Product Code
    GMQ
    Regulation Number
    866.3820
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252114
    Device Name
    MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
    Manufacturer
    Liofilchem s. r. l.
    Date Cleared
    2025-10-02

    (87 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251501
    Device Name
    Visby Medical Men's Sexual Health Test
    Manufacturer
    Visby Medical, Inc.
    Date Cleared
    2025-10-01

    (139 days)

    Product Code
    QEP
    Regulation Number
    866.3393
    Type
    Dual Track
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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