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510(k) Data Aggregation

    K Number
    K251289

    Validate with FDA (Live)

    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
    K231187
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WELLlife COVID-19 Antigen Test Rx is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the WELLlife COVID-19 Antigen Test Rx and followed with a molecular test.

    A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

    Positive results do not rule out co-infection with other respiratory pathogens and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

    Performance characteristics for SARS-CoV-2 were established from April 2023 to February 2024 when SARS-CoV-2 Omicron was dominant. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

    Device Description

    The WELLlife COVID-19 Antigen Test Rx is a lateral flow immunoassay intended for qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for prescription use only.

    The WELLlife COVID-19 Antigen Test Rx consists of the following components:

    • Test Cassette
    • Tube (pre-filled extraction buffer)
    • Swab
    • Tube Holder
    • Quick Reference Instructions (QRI)
    • Instructions for Use (IFU)
    AI/ML Overview

    N/A

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