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510(k) Data Aggregation

    K Number
    K152908
    Device Name
    UCP COMPACT DRUG TESTS
    Date Cleared
    2016-05-03

    (215 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UCP Compact Drug Tests Cards and UCP Compact Drug Tests Cups are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off | |----------------------------|-------------------|------------| | Marijuana: | Delta-9-THC-COOH | 50 ng/mL | | Cocaine: | Benzoylecgonine | 300 ng/mL | | Amphetamine: | D-Amphetamine | 1000 ng/mL | | Methamphetamine: | D-Methamphetamine | 1000 ng/mL | | Opiates: | Morphine | 2000 ng/mL | | Morphine: | Morphine | 300 ng/mL | | Phencyclidine: | Phencyclidine | 25 ng/mL | | Barbiturates: | Secobarbital | 300 ng/mL | | Benzodiazepines: | Oxazepam | 300 ng/mL | | Buprenorphine | Buprenorphine | 10 ng/mL | | Methadone: | Methadone | 300 ng/mL | | EDDP: | EDDP | 300 ng/mL | | Oxycodone: | Oxycodone | 100 ng/mL | | MDMA: | MDMA | 500 ng/mL | | Propoxyphene | Propoxyphene | 300 ng/mL | | Tricyclic Antidepressants: | Nortriptyline | 1000 ng/mL | The tests are intended for over-the-counter (OTC) consumer use as the first step process to provide the consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests will yield preliminary positive results when the prescription drugs Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidentessants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GCMS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.
    Device Description
    UCP Compact Drug Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, EDDP (Methadone metabolite), Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Morphine, Oxycodone, Phencyclidine, Propoxyphene. Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K151213
    Device Name
    UCP Drug Test Mini Cups
    Date Cleared
    2015-08-21

    (107 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for the following drugs and their metabolites in human urine: | Test | Calibrator | Cut-off | |--------------------------|-------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/mL | | Barbiturates | Secobarbital | 300 ng/mL | | Benzodiazepines | Oxazepam | 300 ng/mL | | Buprenorphine | Buprenorphine | 10 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | Delta-9-THC-COOH | 50 ng/mL | | Methadone | Methadone | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 1000 ng/mL | | MDMA | MDMA | 500 ng/mL | | Morphine | Morphine | 300 ng/mL | | Opiates | 2000 | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Phencyclidine | Phencyclidine | 25 ng/mL | | Propoxyphene | Propoxyphene | 300 ng/mL | | Tricyclic Antidepressant | Nortiptyline | 1000 ng/mL | The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding - the second step in the process, along with the materials for shipping the urine speciment to the laboratory, is provided. The test is also intended for prescription use The tests will yield preliminary positive results when the prescription drugs Barbiturates, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
    Device Description
    UCP Drug Test Mini Cups is competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Morphine, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K132812
    Device Name
    UCP MULTI-DRUG TEST KEY CUPS
    Date Cleared
    2014-03-06

    (178 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressant. The test configuration comes with a single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS. The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxyodone, Propxyphene, Tricyclic Antidepressant in urine. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. For Over-The-Counter (OTC) use For In Vitro Diagnostics only
    Device Description
    UCP Multi-Drug Test Key Cups are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K131236
    Device Name
    UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
    Date Cleared
    2013-11-07

    (190 days)

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

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites. UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites. UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
    Device Description
    U
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    K Number
    K131811
    Device Name
    UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
    Date Cleared
    2013-07-19

    (30 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Compact Drug Test Cards and UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
    Device Description
    Not Found
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    K Number
    K130463
    Device Name
    UCP HOME DRUG SCREENING TEST; CARDS, CUPS
    Date Cleared
    2013-05-15

    (82 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Home Drug Screening Test Cards, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressant. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for prescription use. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels. For Over-The-Counter (OTC) use and prescription use For In Vitro Diagnostics only.
    Device Description
    UCP Home Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K123863
    Device Name
    UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
    Date Cleared
    2013-01-09

    (26 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Compact Drug Test Cards, UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressant. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users.
    Device Description
    Not Found
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    K Number
    K122419
    Device Name
    UCP HOME DRUG SCREENING TEST CUPS
    Date Cleared
    2012-11-30

    (113 days)

    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressant. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
    Device Description
    UCP Home Drug Screening Test Cups are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K110515
    Device Name
    UCP DRUG SCREENING TEST CUPS
    Date Cleared
    2011-04-20

    (56 days)

    Regulation Number
    862.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: | Test | Calibrator | Cut-off | |--------------------------|-------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/mL | | Barbiturates | Secobarbital | 300 ng/mL | | Benzodiazepines | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | Delta-9-THC-COOH | 50 ng/mL | | Methadone | Methadone | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 1000 ng/mL | | MDMA | MDMA | 500 ng/mL | | Morphine | Morphine | 300 ng/mL | | Opiate 2000 | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Phencyclidine | Phencylidine | 25 ng/mL | | Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL | The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide 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 for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
    Device Description
    The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: | Test | Calibrator | Cut-off | |--------------------------|-------------------|------------| | Amphetamine | D-Amphetamine | 1000 ng/mL | | Barbiturates | Secobarbital | 300 ng/mL | | Benzodiazepines | Oxazepam | 300 ng/mL | | Cocaine | Benzoylecgonine | 300 ng/mL | | Marijuana | Delta-9-THC-COOH | 50 ng/mL | | Methadone | Methadone | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 1000 ng/mL | | MDMA | MDMA | 500 ng/mL | | Morphine | Morphine | 300 ng/mL | | Opiate 2000 | Morphine | 2000 ng/mL | | Oxycodone | Oxycodone | 100 ng/mL | | Phencyclidine | Phencylidine | 25 ng/mL | | Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL | The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests only provide 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 for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
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    K Number
    K091612
    Device Name
    UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;
    Date Cleared
    2010-02-24

    (266 days)

    Product Code
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    UCP BIOSCIENCES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine: | Test | Calibrator | Cut-off | |-----------------|-------------------|-----------| | Buprenorphine | Buprenorphine | 10 ng/mL | | Amphetamine | D-Amphetamine | 300 ng/mL | | Methamphetamine | D-Methamphetamine | 500 ng/mL | | Cocaine | Benzoylecgonine | 150 ng/mL | The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. The tests only provide 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) or Liguid chromatography/mass spectrometry (LC/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. The tests are not intended to be used in monitoring drug levels.
    Device Description
    UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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