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510(k) Data Aggregation

    K Number
    K991465
    Device Name
    DRUG STOP
    Date Cleared
    1999-12-10

    (227 days)

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

    TEXAS IMMUNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust). DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.
    Device Description
    DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
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    K Number
    K980153
    Device Name
    DRUG CHECK
    Date Cleared
    1998-03-27

    (70 days)

    Product Code
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEXAS IMMUNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DRUG CHECK is a rapid immunochromatography assay designed for the simultaneous qualatative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine. It is an in vitro test intended for professional use. The DRUG CHECK assay provides only a preliminary analytical test result. A more specific alterate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MC) is the preferred confirmatory method. (1) Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
    Device Description
    Not Found
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    K Number
    K973208
    Device Name
    FIRST SIGN
    Date Cleared
    1997-10-20

    (54 days)

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

    TEXAS IMMUNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Texas FIRST SIGH test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.
    Device Description
    Not Found
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    K Number
    K972094
    Device Name
    TARGET CARDIAC TROPONIN I TEST
    Date Cleared
    1997-07-23

    (49 days)

    Product Code
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEXAS IMMUNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A rapid enzyme immunoasay test for the quantitative detection of cardiac troponin-I in serum and heparinized plaama as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.
    Device Description
    Not Found
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    K Number
    K963680
    Device Name
    TARGET MYOGLOBIN TEST
    Date Cleared
    1997-02-06

    (143 days)

    Product Code
    Regulation Number
    866.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEXAS IMMUNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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