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510(k) Data Aggregation

    K Number
    K992068
    Device Name
    STATUS STIK, ACCUSIGN STIK
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1999-07-06

    (18 days)

    Product Code
    DKE,DIO,DJC,DJG,DKZ,LCM
    Regulation Number
    862.3870
    Type
    Special
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STATUS STIK, ACCUSIGN STIK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, evcaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:

    THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
    OPI Morphine 300 ng/mL
    COC Benzoylecgonine 300 ng/mL
    AMP Amphetamine 1000 ng/mL
    MET D-Methamphetamine 1000 ng/mL
    PCP Phencyclidine 25 ng/mL

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding rejection criteria or studies that prove the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a drug screening device, outlining the device's substantial equivalence to predicate devices and its intended use. It does not include performance data, study design details, or acceptance criteria tables.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the associated table, sample sizes, expert qualifications, or other study-specific details.

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