Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K003687
    Device Name
    VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
    Manufacturer
    MEDTOX DIAGNOSTICS, INC.
    Date Cleared
    2000-12-22

    (22 days)

    Product Code
    DKE, DIO, DJG, DKZ, LCM
    Regulation Number
    862.3870
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994405
    Device Name
    INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
    Manufacturer
    ALFA SCIENTIFIC DESIGNS, INC.
    Date Cleared
    2000-06-02

    (157 days)

    Product Code
    DKE
    Regulation Number
    862.3870
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Instant-View Marijuana (THC) Urine Test (Cassette) is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only. The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
    Device Description
    This test is a one-step lateral flow chromatographic immunoassay.
    Ask a Question
    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
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Ask a Question
    K Number
    K991751
    Device Name
    STATUS CUP ACCUSIGN CUP
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1999-06-18

    (25 days)

    Product Code
    DKE, DIO, DJG, DKZ, LAG, LCM
    Regulation Number
    862.3870
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows: | AMP | Amphetamine | 1000 ng/mL | |-----|-----------------------------|------------| | THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL | | COC | Benzoylecgonine | 300 ng/mL | | MET | D-Methamphetamine | 1000 ng/mL | | OPI | Morphine | 300 ng/mL | | PCP | Phencyclidine | 25 ng/mL |
    Device Description
    Not Found
    Ask a Question
    K Number
    K991078
    Device Name
    ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1999-04-15

    (20 days)

    Product Code
    DKE, DIO, DIS, DJG, DKN, DKZ, LCM, LFI
    Regulation Number
    862.3870
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines, barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
    Device Description
    Not Found
    Ask a Question
    K Number
    K983147
    Device Name
    ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1998-09-28

    (20 days)

    Product Code
    DKE, DIO, DIS, DJG, DKN, DKZ, LCM, LFI
    Regulation Number
    862.3870
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
    Device Description
    AccuSign® DOA 8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP) Rapid One-Step Drugs of Abuse Panel Test
    Ask a Question
    K Number
    K982211
    Device Name
    PROFILE-II MODEL 600582
    Manufacturer
    MEDTOX DIAGNOSTICS, INC.
    Date Cleared
    1998-07-29

    (36 days)

    Product Code
    DKE, DIO, DJG, DKZ, LCM
    Regulation Number
    862.3870
    Why did this record match?
    Product Code :

    DKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations: THC Tetrahydrocannabinol 50 ng/mL COC Cocaine (Benzoylecgonine) 300 ng/mL OPS Opiates (Codeine/Morphine) 300 ng/mL AMP Amphetamine 1000 ng/mL PCP Phencyclidine 25 ng/mL This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale. PROFILE-II provides only a preliminary analytical test result. A more specific alternate 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
    PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine.
    Ask a Question

    Page 1 of 1