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

    simpli-COLLECT STI Test

    K Number: K243410 · Decision Jan 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    simpli-COLLECT STI Test
    K Number
    K243410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3385
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Molecular
    Date Received
    November 1, 2024
    Decision Date
    January 30, 2025
    Product Code
    QYA
    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
    QYA System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

    Similar 510(k) Clearances

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

    Simple 2 Test

    FDA 510(k)
    FDA Class 2 ·Microbiology
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    Other Clearances by Abbott Molecular

    K Number Device Name
    K241580 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)