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510(k) Data Aggregation

    K Number
    K130213
    Device Name
    QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
    Date Cleared
    2013-10-18

    (262 days)

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

    LUMIQUICK DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LumiQuick's QuickProfile Single Drugs of Abuse and QuickProfile Multi-Drugs of Abuse Screen Devices are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to nine of the following drugs in a variety of combinations in human urine. Both devices are available in test strip, dip panel, cassette panel and cup formats. The designed cutoff concentrations and direct calibrator for these drugs are as follows: | AMP | Amphetamine | 1000 ng/ml | |------|--------------------------|------------| | BAR | Secobarbital | 300 ng/ml | | BZO | Oxazepam | 300 ng/ml | | COC | Benzoylecgonine | 300 ng/ml | | MTD | Methadone | 300 ng/ml | | MAMP | Methamphetamine | 1000 ng/ml | | OPI | Morphine | 300 ng/ml | | PCP | Phencyclidine | 25 ng/ml | | THC | THC 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml | These devices are intended for prescription use only. These assays provide only 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) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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.
    Device Description
    One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine. Opiates, Phencyclidine, and Marijuana in human urine.
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