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510(k) Data Aggregation

    K Number
    K954996
    Device Name
    TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
    Manufacturer
    TREND SCIENTIFIC, INC.
    Date Cleared
    1996-08-08

    (281 days)

    Product Code
    KHW
    Regulation Number
    866.3220
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREND SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is for the qualitative and/ or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique.
    Device Description
    The device is an Enzyme Linked Immunosorbent Assay (ELISA). The antigen capture takes place in microwells. During the first incubation, antibodies in the patient's serum binds to antigen attached to the test wells. After washing the excess antibodies away, an enzyme complex binds to the antigen-antibody complex. After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex and peroxide. The stop solution ends the reaction and turns the The blue color to yellow. results read may be be spectrophotometrically with a microplate reader or visually.
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    K Number
    K955755
    Device Name
    TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
    Manufacturer
    TREND SCIENTIFIC, INC.
    Date Cleared
    1996-07-11

    (204 days)

    Product Code
    MHJ
    Regulation Number
    866.3220
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREND SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is for the qualitative determination Cryptosporidium antigen in feces. The ELISA test kit is of indicated for use with fecal specimens from patient's with diarrhea aid in the detection of Cryptosporidium gastrointestinal to infection.
    Device Description
    The device is an antigen capture enzyme linked immunosorbent assay (ELISA) for use with stools/ fecal material. The antigen capture takes place in microplate wells. During the first incubation, Cryptosporidium antigens present in the stool supernatant are captured by antibodies attached to the test wells. The second incubation adds an additional anti-Cryptosporidium antibody that "sandwiches" the antigen. The next incubation identifies the antibody/ antigen complex and amplifies the signal by the addition of an anti-immunoglobulin antibody conjugated to horse radish peroxidase (HRP). After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex. The stop solution ends the reaction and turns the blue color to yellow. The results may be read spectrophotometrically with a microplate reader or visually.
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