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510(k) Data Aggregation

    K Number
    K240287
    Device Name
    LYHER® Oral fluid Multi-Drug Test Kit (Cube)
    Manufacturer
    Hangzhou Laihe Biotech Co., Ltd.
    Date Cleared
    2025-03-18

    (411 days)

    Product Code
    DJC, DIO, DJG, DKZ, LCM, LDJ
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hangzhou Laihe Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocanabinol in human oral fluid. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |-----------------------|------------------------------|-----------------| | Opiates(OPI) | Morphine | 40 | | Cocaine (COC) | Benzoylecgonine | 20 | | Amphetamine (AMP) | d-Amphetamine | 50 | | Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 | | Methamphetamine (MET) | d-Methamphetamine | 50 | | Phencyclidine (PCP) | Phencyclidine | 10 | The single or multi-test panels can consist of the above insted analytes in anycombination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
    Device Description
    The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The LYHER® Oral fluid Multi-Drug Test Kit (Cube) device consists of a cube device, an oral fluid collection swab and a package insert.
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    K Number
    K232604
    Device Name
    LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
    Manufacturer
    Hangzhou Laihe Biotech Co., Ltd.
    Date Cleared
    2024-01-10

    (135 days)

    Product Code
    LDJ, DIO, DJC, DJG, DKZ, LCM
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hangzhou Laihe Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |-----------------------|----------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 1000 | | Cocaine (COC) | Benzoylecgonine | 300 | | Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 | | Methamphetamine (MET) | d-Methamphetamine | 1000 | | Opiates(OPI) | Morphine | 2000 | | Phencyclidine (PCP) | Phencyclidine | 25 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
    Device Description
    The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.
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    K Number
    K232597
    Device Name
    LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
    Manufacturer
    Hangzhou Laihe Biotech Co., Ltd.
    Date Cleared
    2024-01-09

    (134 days)

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

    Hangzhou Laihe Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |-----------------------|----------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 1000 | | Cocaine (COC) | Benzoylecgonine | 300 | | Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 | | Methamphetamine (MET) | d-Methamphetamine | 1000 | | Opiates(OPI) | Morphine | 2000 | | Phencyclidine (PCP) | Phencyclidine | 25 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
    Device Description
    The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.
    Ask a Question

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