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510(k) Data Aggregation

    K Number
    K234006
    Device Name
    AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
    Date Cleared
    2024-03-21

    (93 days)

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

    AllSource Screening Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 ng/mL. This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GCMS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostic use only.
    Device Description
    AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch.
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