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510(k) Data Aggregation

    K Number
    K052115
    Device Name
    FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
    Manufacturer
    FIRST CHECK DIAGNOSTICS LLC
    Date Cleared
    2005-12-29

    (147 days)

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

    FIRST CHECK DIAGNOSTICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is a preliminary screening test for the rapid detection of the twelve drugs listed above 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, Phencyclidine at 25 ng/mL, Benzodiazepine at 300 ng/mL, Barbiturates at 300 ng/mL, Methadone at 300 ng/mL, Tri-cyclic Antidepressants at 1,000 ng/mL and Oxycodone at 100 ng/mL. Special condition for use statement: The BAR, BZO, TCA, OXY assay will yield preliminary positive results when BAR, BZO, TCA and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant and oxycodone in urine. The Multi Drug Cup 12 shows the drug was or was not present at the cutoff level. Drug Our 12 enows and 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 for most drugs (HPLC is the spectionely (Greatery method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This device is not intended for workplace testing. This device is intended for Home Use. 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 - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided.
    Device Description
    The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tricyclic Antidepressants (TCA) and Oxycodone (OXY), 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 12 or the sample should be mailed in for confirmation.
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