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510(k) Data Aggregation

    K Number
    K014233
    Device Name
    CAPTIAM SYPHILIS-G ASSAY
    Manufacturer
    TRINITY BIOTECH, PLC
    Date Cleared
    2002-01-24

    (29 days)

    Product Code
    LIP
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY BIOTECH, PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis) CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis. Warning: A positive result is not useful for establishing a diagnosis of syphilis. In most situations, such a result may reflect a prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
    Device Description
    Not Found
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    K Number
    K011709
    Device Name
    UNI-GOLD STREP A TEST KIT
    Manufacturer
    TRINITY BIOTECH, PLC
    Date Cleared
    2001-11-08

    (157 days)

    Product Code
    GTZ, GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY BIOTECH, PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also be used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the rapid diagnosis of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture.
    Device Description
    The extracted sample flows through an absorbent pad containing anti-Strep A antibody conjugated to colloidal gold which binds group A Streptoccal antigen if present, forming an antigen-antibody complex. As this complex travels along the membrane, it becomes immobilised at the test region, which is impregnated with a rabbit polyclonal anti-Strep A antibody, resulting in the formation of a pink/red line. A pink/red line will also appear in the control region of the test indicating proper functioning of the test. In the absence of group A Streptococcal antigen, a pink/red line will only appear in the control line.
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    K Number
    K001525
    Device Name
    CAPTIA SYPHILIS-G ELISA TEST SYSTEM
    Manufacturer
    TRINITY BIOTECH, PLC
    Date Cleared
    2000-11-29

    (197 days)

    Product Code
    LIP
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY BIOTECH, PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991697
    Device Name
    UNI-GOLD H. PYLORI
    Manufacturer
    TRINITY BIOTECH, PLC
    Date Cleared
    1999-12-21

    (217 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY BIOTECH, PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.
    Device Description
    As the sample flows laterally through the membrane, the specific antibody bindingprotein dye conjugate binds to the human immunoglobulins in the sample. If the sample contains IgG antibodies to H. pylori, the complex binds to the antigens on the solid phase of the device's test region producing a red/pink (red) line. In the absence of H. pylori antibodies, no line appears in the test region of the device. A procedural-functional control is built in to each device. As the sample migrates across the control region, the appearance of a red line at the control region indicates correct procedure and a functional device.
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    K Number
    K982373
    Device Name
    UNI-GOLD STREP A TEST KIT
    Manufacturer
    TRINITY BIOTECH, PLC
    Date Cleared
    1999-02-11

    (219 days)

    Product Code
    GTY
    Regulation Number
    866.3740
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINITY BIOTECH, PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trinity Biotech Uni-Gold™ Strep A Test Kit is a rapid immunoassay for the qualitative detection of Streptococcal A antigen from throat swabs, or the confirmation of beta-hemolytic colonies obtained from blood agar plates. The Trinity Biotech Uni-Gold™ Strep A Test Kit is intended for use in hospital laboratories and physicians' offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.
    Device Description
    Immunoassay: Strep A antigen, when present, binds to the anti-Strep A antibody conjugated to a gold dye. As this complex travels along the membrane, it becomes immobilized at the test region, resulting in the formation of a red line. Excess antibodygold conjugate further migrates along the membrane and binds to the control region, forming another red line. In the absence of Strep A antigen, a red line will only be formed at the control region.
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