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510(k) Data Aggregation

    K Number
    K223690
    Device Name
    iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
    Manufacturer
    Shenzhen YHLO Biotech Co., LTD.
    Date Cleared
    2023-12-11

    (367 days)

    Product Code
    DHA, JJE
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen YHLO Biotech Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG ß-subunit (ß-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods. Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.
    Device Description
    iFlash-HCG that includes testing reagents and three levels of calibrators is based on chemiluminescence immunoassay. HCG and hCG ß-subunit (ß-hCG) in the sample reacts with anti-HCG antibody coated paramagnetic microparticles and acridinium-labeled anti-HCG antibody conjugate to form a sandwich complex, after chemiluminescent reaction, HCG amount in the sample is derived from RLUs (relative light units) using a calibration curve. iFlash-HCG is intended to be used on Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.
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