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510(k) Data Aggregation

    K Number
    DEN230024
    Device Name
    Technozym ADAMTS13 Activity
    Date Cleared
    2024-02-28

    (328 days)

    Product Code
    Regulation Number
    864.7297
    Why did this record match?
    Applicant Name (Manufacturer) :

    Technoclone Herstellung von Diagnostika und Arzneimitteln Gm

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Technozvm ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet poor human citrated plasma. The assay is intended to be used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA).
    Device Description
    The Technozym ADAMTS13 Activity assay is an enzyme linked immunosorbent assay (ELISA) used for detection of ADAMTS13 activity in citrated human plasma. The assay contains: ADAMTS13 Activity anti-GST coated test plate microplate coated with anti-GST antibody, ADAMTS13 Activity GST-VWF73 reagent that contains GST tagged peptide of 73 amino acids from the A2 domain of VWF with specific cleavage site for ADAMTS13 and serves as the in vitro substrate for ADAMTS13, ADAMTS13 Activity Calibrators-consists of six vials containing lyophilized plasma, each with a different level of ADAMTS13 activity, ADAMTS13 Activity Controls consists of two vials of lyophilized plasma, each with high or low levels of ADAMTS13 activity, ADAMTS13 Activity Conjugate - reagent that contains horseradish peroxidase (HRP) conjugated monoclonal antibody directed against the neoepitope exposed due to cleavage of GST-VWF73 by ADAMTS13 present in plasma, ADAMTS13 TMB substrate reagent contains tetramethylbenzidine (TMB) substrate for HRP, ADAMTS13 Activity Stop Solution reagent contains 2.5% sulfuric acid for stopping the conversion of TMB substrate.
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