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    K Number
    DEN240020

    Validate with FDA (Live)

    Device Name
    Visby Medical Women's Sexual Health Test
    Manufacturer
    Visby Medical, Inc.
    Date Cleared
    2025-03-28

    (319 days)

    Product Code
    SEA
    Regulation Number
    866.3386
    Type
    Direct
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Panel |
    |-----------------|----------------|-------------------|-------|
    | SEA | Class II | 21 CFR 866.3386
    Class: II
    Regulation: 21 CFR 866.3386

    DEN240020 - Page 19 of 19

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Visby Medical Women's Sexual Health Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected vaginal swab specimens. This test is intended to be sold over-the-counter (OTC) for use by females suspected of sexually transmitted infection with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. This test is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop or change any treatments without a healthcare provider.

    Device Description

    The Visby Medical Women's Sexual Health Test is a single-use (disposable), automated, rapid, compact device containing a PCR-based assay for the direct qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal swab specimens tested at home.

    The Visby Medical Women's Sexual Health Test system includes the Visby Medical Women's Sexual Health device; the Visby Medical Women's Sexual Health Vaginal Specimen Collection Kit (flocked swab and media); a sample transfer syringe; tube holder; Visby power adaptor; printed instructions and Frequently Asked Questions (FAQs); and smartphone application (Visby Medical Application).

    The user self-collects the vaginal swab specimen using the provided flocked swab ("Visby Medical Women's Sexual Health Collection Swab") and elutes it into the Visby Medical Women's Sexual Health Collection Media. Using the provided sample transfer syringe, the user transfers the collection media (containing their specimen) into the sample port of the device (~650 µL). The user then slides a purple switch on the front of the device to both close the sample port and initiate the fully automated testing process. A blinking white light indicates the test is in progress. Test results are available in less than 30 minutes.

    AI/ML Overview

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