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510(k) Data Aggregation

    K Number
    K033566
    Device Name
    MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
    Manufacturer
    RAPID DIAGNOSTICS, INC.
    Date Cleared
    2004-05-17

    (187 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, DJR, JXM, LCM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAPID DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml). The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.
    Device Description
    The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine.
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    K Number
    K020716
    Device Name
    RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
    Manufacturer
    RAPID DIAGNOSTICS, INC.
    Date Cleared
    2002-05-06

    (62 days)

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

    RAPID DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/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.
    Device Description
    The Rapid Drug tests are 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 antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cutoff level, it will prevent the binding of drug conjugate to the antibody. As a result, 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.
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    K Number
    K003809
    Device Name
    RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
    Manufacturer
    RAPID DIAGNOSTICS, INC.
    Date Cleared
    2001-04-20

    (133 days)

    Product Code
    DKZ, DIO, DJC, DJG, JXM, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAPID DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981770
    Device Name
    RAPIDHCG PREGNANCY TEST
    Manufacturer
    RAPID DIAGNOSTICS, INC.
    Date Cleared
    1998-06-05

    (17 days)

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

    RAPID DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RapidHCG Pregnancy Test is a qualitative test that detects the presence of human Chorionic Gonadotropin (hCG) in human urine specimens. The test is a visual one step, in vitro assay. The test is intended for professional use to help diagnose pregnancy in hospital and clinical lab.
    Device Description
    The test is a visual one step, in vitro assay.
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