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510(k) Data Aggregation

    K Number
    K993945
    Device Name
    BIONIKE AQ PHENCYCLIDINE (PCP) TEST
    Manufacturer
    BIONIKE LABORATORIES, INC.
    Date Cleared
    1999-12-07

    (18 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONIKE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bionike's AQ™ Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated". Bionike Laboratories' AQ™ Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.
    Device Description
    Bionike Laboratories' AQ™ Phencyclidine (PCP) Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 25 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
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    K Number
    K972384
    Device Name
    AQ ONE STEP COCAINE TEST
    Manufacturer
    BIONIKE LABORATORIES, INC.
    Date Cleared
    1997-08-06

    (41 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONIKE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
    Device Description
    Not Found
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    K Number
    K971841
    Device Name
    BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
    Manufacturer
    BIONIKE LABORATORIES, INC.
    Date Cleared
    1997-06-25

    (37 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONIKE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
    Device Description
    Not Found
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    K Number
    K971361
    Device Name
    AQ OPIATES (MORPHINE) TEST
    Manufacturer
    BIONIKE LABORATORIES, INC.
    Date Cleared
    1997-06-06

    (56 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONIKE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
    Device Description
    Not Found
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    K Number
    K960992
    Device Name
    BIONIKE A/Q PREGNANCY TEST
    Manufacturer
    BIONIKE LABORATORIES, INC.
    Date Cleared
    1996-04-25

    (44 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIONIKE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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