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510(k) Data Aggregation

    K Number
    K063379
    Device Name
    AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220
    Manufacturer
    AMEDICA BIOTECH, INC.
    Date Cleared
    2006-12-11

    (33 days)

    Product Code
    DKZ,DIO,DIS,DJC,DJG,DJR,JXM,JXN,LCM,LDJ,LFG
    Regulation Number
    862.3100
    Type
    Special
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220

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

    The Amedica Drug Screen Test Cup II THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, propoxyphene and oxycodone in human urine at the following cutoff concentration:

    THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic 50 ng,ml
    COC Benzoylecgonine 300 ng,ml
    OPI Morphine 2000 ng,ml
    OPI Morphine 300 ng,ml
    AMP Amphetamine 1000 ng,ml
    MET Methamphetamine 1000 ng,ml
    PCP Phencyclidine 25 ng,ml
    MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml
    BAR Secobarbital 300 ng/ml
    BZO Oxazepam 300 ng/ml
    MTD Methadone 300 ng/ml
    TCA Nortriptyline 1000 ng/ml
    PPX Propoxyphene 300 ng/ml
    OXY Oxycodone 300 ng/ml

    This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.

    This assay provides only a preliminary result. A more specific alternative 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 used.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a drug screen test cup. It does not contain the detailed study information or acceptance criteria to fully answer the request. The document describes the device's intended use and the substances it tests for with their respective cutoff concentrations, but it does not include data on the device's performance (e.g., sensitivity, specificity), the study design, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot populate the table or provide the requested details about the study that proves the device meets acceptance criteria. The information provided in the document is limited to regulatory clearance and device specifications.

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