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510(k) Data Aggregation

    K Number
    K244043
    Device Name
    AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
    Manufacturer
    Hangzhou Alltest Biotech Co.,Ltd
    Date Cleared
    2025-02-27

    (59 days)

    Product Code
    NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3100
    Why did this record match?
    Search-Everything :

    Matched: '862.3640'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |---------------------------------------------------------------------------------------------|-------------------| | Amphetamine (AMP) | 500 or 1000 ng/mL | | Buprenorphine (BUP) | 10 ng/mL | | Secobarbital (BAR) | 300 ng/mL | | Benzodiazepines (BZO) | 300 ng/mL | | Cocaine (COC) | 150 or 300 ng/mL | | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL | | Methamphetamine (MET) | 500 or 1000 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | | Morphine (MOP/OPI) | 300 or 2000 ng/mL | | Methadone (MTD) | 300 ng/mL | | Oxycodone (OXY) | 100 ng/mL | | Phencyclidine (PCP) | 25 ng/mL | | Nortriptyline (TCA) | 1000 ng/mL | | Marijuana (THC) | 50 ng/mL | | Tramadol (TRA) | 100 ng/mL | | Propoxyphene (PPX) | 300 ng/mL | | Fentanyl(FYL) | 1 ng/mL | | 6-monoacetylmorphine (6-MAM) | 10 ng/mL | | AllTest Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination | | est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of: | Drug (Identifier) | Calibrator | Cut-off (ng/mL) | |--------------------------------------------------------------|-------------------------------------------------------|-----------------| | Amphetamine (AMP) | d-Amphetamine | 500 or 1000 | | Buprenorphine (BUP) | Buprenorphine | 10 | | Secobarbital (BAR) | Secobarbital | 300 | | Benzodiazepines (BZO) | Oxazepam | 300 | | Cocaine (COC) | Benzoylecgonine | 150 or 300 | | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine | 300 | | Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 | | Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 | | Morphine (MOP/OPI) | Morphine | 300 or 2000 | | Methadone (MTD) | Methadone | 300 | | Oxycodone (OXY) | Oxycodone | 100 | | Phencyclidine (PCP) | Phencyclidine | 25 | | Nortriptyline (TCA) | Nortriptyline | 1000 | | Marijuana (THC) | 1-nor-Δ9-THC-9 COOH | 50 | | Tramadol (TRA) | Tramadol | 100 | | Propoxyphene (PPX) | Propoxyphene | 300 | | Fentanyl(FYL) | Fentanyl | 1 | | 6-monoacetylmorphine (6-MAM) | 6-monoacetylmorphine | 10 | AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K232736
    Device Name
    Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
    Manufacturer
    Chemtron Biotech, Inc.
    Date Cleared
    2023-12-20

    (104 days)

    Product Code
    DJG, DIO, DIS, DJC, DJR, DKZ, DNK, JXM, JXN, LAF, LCM, LDJ, LFG
    Regulation Number
    862.3650
    Why did this record match?
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    Matched: '862.3640'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows: The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only. The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The Chemtrue® Drug Screen Fentany1 / Tramadol Cup Test detects and is calibrated against norfentany1, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels. The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated. The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only. The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentany, Marijuana, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device. The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Benzodiazepines, Antidepressants. The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device. The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Tricyclic Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Antidepressants.
    Device Description
    The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.
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    K Number
    K233019
    Device Name
    AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
    Manufacturer
    Hangzhou AllTest Biotech Co.,Ltd
    Date Cleared
    2023-12-13

    (82 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, DJR, DNK, JXM, LAF, LCM, LDJ, LFG, NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW
    Regulation Number
    862.3100
    Why did this record match?
    Search-Everything :

    Matched: '862.3640'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) | Cut-off level ng/mL ---|--- Amphetamine (AMP) | 500 or 1000 ng/mL Buprenorphine (BUP) | 10 ng/mL Secobarbital (BAR) | 300 ng/mL Benzodiazepines (BZO) | 300 ng/mL Cocaine (COC) | 150 or 300 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL Methamphetamine (MET) | 500 or 1000 ng/mL Methylenedioxymethamphetamine (MDMA) | 500 ng/mL Morphine (MOP/OPI) | 300 or 2000 ng/mL Methadone (MTD) | 300 ng/mL Oxycodone (OXY) | 100 ng/mL Phencyclidine (PCP) | 25 ng/mL Nortriptyline (TCA) | 1000 ng/mL Marijuana (THC) | 50 ng/mL AllTest Multi-Drug Rapid Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) | Cut-off level ng/mL ---|--- Amphetamine (AMP) | 500 or 1000 ng/mL Buprenorphine (BUP) | 10 ng/mL Secobarbital (BAR) | 300 ng/mL Benzodiazepines (BZO) | 300 ng/mL Cocaine (COC) | 150 or 300 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL Methamphetamine (MET) | 500 or 1000 ng/mL Methylenedioxymethamphetamine (MDMA) | 500 ng/mL Morphine (MOP/OPI) | 300 or 2000 ng/mL Methadone (MTD) | 300 ng/mL Oxycodone (OXY) | 100 ng/mL Phencyclidine (PCP) | 25 ng/mL Nortriptyline (TCA) | 1000 ng/mL Marijuana (THC) | 50 ng/mL AllTest Multi-Drug Rapid Test Panel offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of: Drug (Identifier) | Calibrator | Cut-off (ng/mL) ---|---|--- Amphetamine (AMP) | d-Amphetamine | 500 or 1000 Buprenorphine (BUP) | Buprenorphine | 10 Secobarbital (BAR) | Secobarbital | 300 Benzodiazepines (BZO) | Oxazepam | 300 Cocaine (COC) | Benzoylecgonine | 150 or 300 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 500 Morphine (MOP/OPI) | Morphine | 300 or 2000 Methadone (MTD) | Methadone | 300 Oxycodone (OXY) | Oxycodone | 100 Phencyclidine (PCP) | Phencyclidine | 25 Nortriptyline (TCA) | Nortriptyline | 1000 Marijuana (THC) | 11-nor-A9-THC-9 COOH | 50 AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) | Calibrator | Cut-off (ng/mL) ---|---|--- Amphetamine (AMP) | d-Amphetamine | 500 or 1000 Buprenorphine (BUP) | Buprenorphine | 10 Secobarbital (BAR) | Secobarbital | 300 Benzodiazepines (BZO) | Oxazepam | 300 Cocaine (COC) | Benzoylecgonine | 150 or 300 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 Methamphetamine (MET) | d-Methamphetamine | 500 or 1000 Methylenedioxymethamphetamine (MDMA) | d.l-Methylenedioxymethamphetamine | 500 Morphine (MOP/OPI) | Morphine | 300 or 2000 Methadone (MTD) | Methadone | 300 Oxycodone (OXY) | Oxycodone | 100 Phencyclidine (PCP) | Phencyclidine | 25 Nortriptyline (TCA) | Nortriptyline | 1000 Marijuana (THC) | 11-nor-Δ9-THC-9 COOH | 50 AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
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    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?
    Search-Everything :

    Matched: '862.3640'

    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?
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    Matched: '862.3640'

    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
    K193480
    Device Name
    BIOEASY Multi-Drug Test Cup
    Manufacturer
    Shenzhen Bioeasy Biotechnology Co.,Ltd.
    Date Cleared
    2020-01-31

    (46 days)

    Product Code
    NGL, NFT, NFV, NFW, NFY, NGG, NGI, NGM, PTG, PTH, QAW, QBF
    Regulation Number
    862.3650
    Why did this record match?
    Search-Everything :

    Matched: '862.3640'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOEASY Multi-Drug Test Cup Tests are 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 and d-Propoxyphene 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 | | Marijuana | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 300 ng/mL or 2000 ng/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 | Configuration of the BIOEASY Multi-Drug Test Cup tests 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. For in vitro diagnostic use only.
    Device Description
    The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, 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
    K191099
    Device Name
    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
    Manufacturer
    Atlas Medical
    Date Cleared
    2019-10-03

    (161 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, DJR, DNK, JXM, JXN, LCM, LDJ, LFG
    Regulation Number
    862.3100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments: Amphetamine (AMP), Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Oxycodone (OXY), Cocaine (COC), Nortriptyline, Methamphetamine (MET), Phencyclidine (PCP), Marijuana (THC), Secobarbital, Oxazepam, Methadone (MTD), Propoxyphene (PPX), Buprenorphine(BUP). The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show 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 (GC/MS). 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
    Atlas Multi-Drugs Screening Test cup format is single use device. The user collects urine in the cup to the recommended volume. The reaction is initiated by movement the sample to the strip. The strips are incorporated into the sides of sample cup. Atlas Multi-Drugs Screening Test panel format is single use dip card device. The user inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the strip. Atlas Multi-Drugs Screening Tests (Cup and Panel Formats) detect up to 14 drugs.
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    K Number
    K182738
    Device Name
    Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
    Manufacturer
    Hangzhou AllTest Biotech Co., Ltd
    Date Cleared
    2019-03-27

    (180 days)

    Product Code
    DKZ, DIO, DIS, DJC, DJG, DJR, DNK, JXM, LAF, LCM, LDJ, LFG, NFT, NFV, NFW, NFY, NGG, NGI, NGL, NGM, PTG, PTH, QAW
    Regulation Number
    862.3100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 indicated. For Prescription Use. The Single and Multi-Drug Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 indicated. For Prescription Use. The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 indicated. For Prescription Use. The Single and Multi-Drug Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 indicated. For Prescription Use. The Single Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 indicated. For Prescription Use. The Single and Multi-Drug Home Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay 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 indicated. For Over-The-Counter use. The Single and Multi-Drug Home Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, 50ng/mL, Methadone 300ng/mL, Methamphetamine Mariiuana 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay 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 indicated. For Over-The-Counter use. The Single Drug Home Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, 50ng/mL. Methadone Marijuana 500ng/mL. Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1.5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL. This assay 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 indicated. For Over-The-Counter use.
    Device Description
    The Candidate Drug Screen Tests are rapid lateral flow immunoassays in which drugprotein conjugates in the test device compete with drugs or drug metabolites that may be present in urine. On each test strip, a drug-protein conjugate is added to the test band of the membrane known as the test region (T), and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. Anti-drug antibodies derived from sheep and/or mice are used on the candidate tests. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody- gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.
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    K Number
    K180878
    Device Name
    BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx
    Manufacturer
    Shanghai Venture Bio-Tech CO., Ltd.
    Date Cleared
    2018-12-17

    (258 days)

    Product Code
    DJC, DIO, DKZ, DNK, JXM, LDJ, NFT, NFV, NFW, NFY, NGG, NGI
    Regulation Number
    862.3610
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    Matched: '862.3640'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine. Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrators | Cut-off Level | |-----------------------|-------------------|---------------| | Amphetamine (AMP) | d-Amphetamine | 1000ng/ml | | Oxazepam | Oxazepam | 300ng/ml | | Cocaine (COC) | Benzoylecgonine | 300ng/ml | | Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml | | Morphine(MOP) | Morphine | 300ng/ml | | Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml | The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over the counter use. BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrators | Cut-off Level | |-----------------------|-------------------|---------------| | Amphetamine (AMP) | d-Amphetamine | 1000ng/ml | | Oxazepam | Oxazepam | 300ng/ml | | Cocaine (COC) | Benzoylecgonine | 300ng/ml | | Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml | | Morphine(MOP) | Morphine | 300ng/ml | | Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml | The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.
    Device Description
    The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained
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    K Number
    K180879
    Device Name
    BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
    Manufacturer
    SHANGHAI VENTURE BIO-TECH CO., LTD.
    Date Cleared
    2018-12-14

    (255 days)

    Product Code
    DKZ, DIO, DJC, DNK, JXM, LDJ, NFT, NFV, NFW, NFY, NGG, NGI
    Regulation Number
    862.3100
    Why did this record match?
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    Matched: '862.3640'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepan, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over the counter use. BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoasay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.
    Device Description
    BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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