Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030912
    Device Name
    THYRO TEST
    Manufacturer
    Date Cleared
    2003-07-25

    (123 days)

    Product Code
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    THRYOTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ThyroTest is a whole blood, qualitative assay for the detection of an increased level of TSH (Thyroid Stimulating Hormone). An increase level of TSH can be an indication of primary hypothyroidism. For professional use only.
    Device Description
    Purified Polyclonal anti TSH antibodies are passively absorbed on the absorbent membrane. Anti-TSH monoclonal antibodies are absorbed on colloidal gold and then mixed in a protein matrix to obtain the final dye conjugate. Once applied to the specimen well, blood sample undergoes vertical capillary filtration through the porous filtration system. The blood cells are retained in the top layers while the liquid phase (plasma) reaches the bottom membrane layer. The buffer, when applied to the specimen well, flows along the bottom membrane layer, mixes with plasma and migrates horizontally along the test membrane. If TSH is present in the sample in concentrations at or above the detection level, labeled antibody-dye conjugates binds to it, forming an antigen-antibody-dye complex. This complex is then captured by antibody immobilized in the Test Zone ("T") of the membrane, producing a visible pink-rose color band on the membrane. A similarly colored conjugate is captured by a parallel immunochemical reaction in the Control Zone ("C") of the membrane. A distinctive control band is the marker of proper test performance.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1