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    K Number
    K251753
    Device Name
    GenaCheck COVID-19 Rapid Self-Test
    Manufacturer
    Genabio Diagnostics Inc
    Date Cleared
    2025-09-05

    (88 days)

    Product Code
    QYT
    Regulation Number
    866.3984
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K213804,K231306,K233373
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K213804, K231306

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

    The GenaCheck COVID-19 Rapid Self-Test is a visually read lateral flow immunoassay test intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

    This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

    All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.

    Positive results do not rule out co-infection with other respiratory pathogens.

    This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

    The performance characteristics for SARS-CoV-2 were established from March 2024 to October 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspect.

    Device Description

    The GenaCheck® COVID-19 Rapid Self-Test is a rapid, qualitative latex particles based immunochromatography test. The test is designed to detect nucleocapsid protein antigen in anterior nasal swab specimens from individuals who show symptoms of COVID-19 infection within the first five (5) days of symptom onset. The GenaCheck® COVID-19 Rapid Self-Test is validated for use from direct specimens testing without transport media.

    The test package is composed of the following components:

    • Test Cassette within a Foil Pouch
    • Lysis Buffer
    • Anterior Nasal Swab
    • Quick Reference Instructions

    The test cassette contains a test strip (binding pad) in a plastic housing. The binding pad is a nitrocellulose membrane with two regions: test region (T) and control region (C).

    AI/ML Overview

    N/A

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