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510(k) Data Aggregation

    K Number
    K231137
    Device Name
    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
    Manufacturer
    Xenta Biomedical Science Co., Ltd.
    Date Cleared
    2023-05-19

    (28 days)

    Product Code
    DKZ, DIS, DJG, DJR, JXM, LCM
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xenta Biomedical Science Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test Barbiturates (BAR) Benzodiazepines (BZO) Amphetamine (AMP) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) - Calibrator Secobarbital Oxazepam D-Amphetamine Methadone Oxycodone Phencyclidine Cut-off level 300 ng/mL 300 ng/mL 1000 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use. The assays provide only a preliminary analytical test 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 indicated.
    Device Description
    Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Barbiturate, Benzodiazepine, Amphetamine, Methadone, Oxycodone, Phencyclidine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument. The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
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    K Number
    K222955
    Device Name
    Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
    Manufacturer
    Xenta Biomedical Science Co., Ltd.
    Date Cleared
    2023-02-06

    (132 days)

    Product Code
    DJG, DIO, DJC, LDJ
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xenta Biomedical Science Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off level | |--------------------------------------|-----------------------------------|---------------| | Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL | | Cocaine (COC) | Benzoylecgonine | 300 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL | | Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL | | Morphine 300 (MOP) | Morphine | 300 ng/mL | The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use. The assays provide only a preliminary analytical test 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 indicated.
    Device Description
    Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Cocaine, Marijuana, Methamphetamine, Morphine, Methylenedioxymethamphetamine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument. The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
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