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510(k) Data Aggregation

    K Number
    K202453
    Device Name
    SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
    Manufacturer
    Safecare Biotech(Hangzhou)Co.,Ltd.
    Date Cleared
    2021-03-24

    (209 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Safecare Biotech(Hangzhou)Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |-----------------------------------------------------|---------------| | Amphetamine | 500ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 150ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 500ng/mL | | Morphine | 300ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |-----------------------------------------------------|---------------| | Amphetamine | 500ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 150ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 500ng/mL | | Morphine | 300ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
    Device Description
    The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
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    K Number
    K201120
    Device Name
    SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
    Manufacturer
    Safecare Biotech(Hangzhou)Co.,Ltd.
    Date Cleared
    2020-05-27

    (30 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Safecare Biotech(Hangzhou)Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
    Device Description
    The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
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    K Number
    K181968
    Device Name
    SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
    Manufacturer
    Safecare Biotech(Hangzhou)Co.,Ltd.
    Date Cleared
    2018-08-20

    (27 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGL, PTG, PTH
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Safecare Biotech(Hangzhou)Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |-------------------|---------------| | Amphetamine | 1000 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Cannabinoids | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 2000 ng/mL | | Secobarbital | 300 ng/mL | | Methadone | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |-------------------|---------------| | Amphetamine | 1000 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Cannabinoids | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 2000 ng/mL | | Secobarbital | 300 ng/mL | | Methadone | 300 ng/mL | Configuration of SAFECARE® Multi-Drug Urine Test Cup combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
    Device Description
    The SAFECARE Dip Card Tests and SAFECARE Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Secobarbital and Methadone (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
    Ask a Question

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