LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253318

    Validate with FDA (Live)

    Device Name
    Clungene RSV Antigen Rapid Test
    Manufacturer
    Hangzhou Clongene Biotech Co., Ltd.
    Date Cleared
    2026-01-30

    (122 days)

    Product Code
    GQG
    Regulation Number
    866.3480
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    0 - 97
    Reference & Predicate Devices
    K240280
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The test is intended for in vitro diagnostic use as an aid in the diagnosis of RSV infections.

    Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or patient management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an FDA-cleared molecular assay.

    Device Description

    The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The nasopharyngeal swab from individuals is processed by the extraction buffer in buffer tube. After the extracted sample is added into the specimen well, the respiratory syncytial virus (RSV) nucleoprotein antigen in the sample will react with anti-RSV antigen antibody conjugated with color micro particles to form an antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated anti-RSV antigen antibody. If the specimen contains RSV nucleoprotein antigen, a colored line will appear in the test line (T) region indicating a positive result. If the specimen does not contain RSV nucleoprotein antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line (C) region indicating that proper volume of specimen has been added and membrane wicking has occurred.

    The test result should be read at 15-20 minutes after adding the extracted sample is added into the specimen well. One line in the control line region (C), and another line in the test line region (T) indicates a positive result, regardless of color intensity. When only One line is present in the control region(C) and no line is present in the test line region (T) results are negative result. If the control line(C) fails to appear, the result is invalid, and the operator should review the procedure and repeat the test with a new test cassette.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1