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510(k) Data Aggregation

    K Number
    K030211
    Device Name
    RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
    Manufacturer
    ICN BIOMEDICALS, INC.
    Date Cleared
    2003-06-13

    (143 days)

    Product Code
    DKX
    Regulation Number
    862.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICN BIOMEDICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result. Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
    Device Description
    The RapidBAR test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-barbiturate antibody between barbiturate-protein conjugate and free drug which may be present in the urine specimen being tested. When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
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    K Number
    K023252
    Device Name
    RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
    Manufacturer
    ICN BIOMEDICALS, INC.
    Date Cleared
    2002-11-22

    (53 days)

    Product Code
    DJR
    Regulation Number
    862.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICN BIOMEDICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result. Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
    Device Description
    Rapid Methadone Test Strip is a dipstick device for detecting the presence or absence of the tested drug. The test strip is also used for the composition of Rapid Methadone Test Card. These test devices are manufactured with the same formulation and procedure except the test card consists a plastic housing containing one methadone test strip. There is no any functional design that may affect the test strip's performance in the test card. A. Test Strip Test strips that containing absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, are used to assemble Rapid Methadone Test Strip as shown below: B. Test Card Format The above test strip that contains an absorbent pad, coated membrane, gold conjugate pad, and sample pad with adhesive sticker in each strip, is used to assemble the Test Card Device as shown below.
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