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510(k) Data Aggregation

    K Number
    K051966
    Device Name
    FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
    Date Cleared
    2005-09-07

    (49 days)

    Product Code
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is a screening test for the rapid detection of one to seven of the above listed drugs in a variety of combinations in human urine. The designated cut-off concentrations of these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing of the second step in the process, along with the materials for shipping the unne speciment o the laboratory, is provided.
    Device Description
    The First Check® Multi Drue Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP), like other commercially available drug screening tests, qualitatively detects the presence or absence of the above listed drugs and their metabolites in urine, using a one step. rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug complexes. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly. If a control line does not appear for any reason, the results are considered invalid and should not be interpreted. The sample should either be retested using a new First Check Multi Drug Cup 7 or the sample should be mailed in for confirmation.
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