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510(k) Data Aggregation

    K Number
    K152590
    Device Name
    ACCU NEWS Drug Screening Test Card/Urine Cup
    Manufacturer
    Date Cleared
    2016-04-15

    (218 days)

    Product Code
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORETESTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCU NEW® Drug Screening Test Card Urine Cup are immunochromatographic assays for the qualitative determination of the drugs/drug metabolites in human urine. The test cutoff concentrations and the tests are calibrated to are as follows: | Analyte | Abbreviation | Calibrator | Cutoff (ng/ml) | |-----------------|--------------|---------------------|----------------| | Amphetamine | AMP | d-Amphetamine | 1000 | | Methamphetamine | MET | d-Methamphetamine | 1000 | | Morphine | MOP | Morphine | 300 | | Cocaine | COC | Benzoylecgonine | 300 | | Marijuana | THC | 11-Nor-9-THC-9-COOH | 50 | The ACCU NEWS® Drug Screening Test Card /Urine Cup can consist of any combination of the drug analytes listed above. For in vitro diagnostic use only. The tests are intended for both prescription and over-the-counter (OTC) use. The device provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectronetry (LCMS) are the preferred confirmatory methods. Clinical consideration and professional judgement should be exercised for any drugs of abuse test results, particularly when preliminary results are positive.
    Device Description
    ACCU NEWS® Drug Screening Test Card/Urine Cup is based on the principle of highly specific immunochemical reactions between antigens and antibodies. The devices utilize a competitive immunoassay in which a drug-protein conjugate immobilized on a nitrocellulose membrane competes with the drug target present in human urine for limited binding sites presented in colloidal gold-labeled mouse monoclonal antibody. The presence of a color band at a test region (coated with drug-protein conjugate) indicates a negative result for that particular test. The absence of a color band at the test region indicates presumptive positive result for that particular test. A color band at the control region, which was coasted with goat anti-mouse polyclonal antibody, should always appear regardless of the presence of the drug or its metabolites. The presence of the control band during testing serves as a built-in procedural control, indicating the completion of the test and validity of the operation. There are two formats of the test device, and both of them operate on the same basic principle. ACCU NEWS® Drug Screening Test Card device consists of individual test strips encased in a protective plastic case, and the device can detect up to 5 drugs/drug metabolites simultaneously. The ACCU NEWS® Drugs of Abuse Screening Urine Cup consists of the assembled test card integrated into a sample collection cup. Both formats are single-use, in vitro diagnostic devices. Test results interpretation: Negative: Two pink lines appear, one in the control region and the other in the test region. Regardless of the color intensity, any line formed in the test region, even if it is faint, the result is considered negative. Positive: Only one pink line appears in the control region, and no line appears in the test region. Invalid: If no line appears in the control region, the test result is invalid regardless of the absence or presence of the test line.
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    K Number
    K150063
    Device Name
    One Step hCG Pregnancy Test
    Manufacturer
    Date Cleared
    2015-10-02

    (262 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Coretests, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
    Device Description
    ACCU NEWS "M One Step hCG Pregnancy Test is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. It is built on a basic lateral flow immunoassay test strip model containing 6 components as illustrated below: The nitrocellulose membrane is coated with Goat anti-mouse IgG polyclonal antibody on the control line and anti-alpha hCG mouse monoclonal antibody on the test line. The conjugate pad contains colloidal-gold-labeled anti-beta mouse monoclonal hCG antibody. When urine specimen is drawn through the sample pad, the hCG present in the urine will react with the anti-beta monoclonal hCG antibody on the conjugate pad and the antialpha monoclonal hCG antibody on the test line to develop visible lines in the test region. The ACCU NEWS TM One Step hCG Pregnancy Test is available in three different formats: 1) strip, 2) cassette, and 3) midstream.
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