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510(k) Data Aggregation

    K Number
    K232732
    Device Name
    Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
    Manufacturer
    Co-Innovation Biotech Co., Ltd.
    Date Cleared
    2024-01-17

    (132 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Co-Innovation Biotech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL. The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use. The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid 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 obtained.
    Device Description
    Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 20 ng/mL. The tests can be performed without the use of an instrument. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 50 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.
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    K Number
    K153050
    Device Name
    Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
    Manufacturer
    Co-Innovation Biotech Co., Ltd
    Date Cleared
    2016-04-26

    (189 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?
    Applicant Name (Manufacturer) :

    Co-Innovation Biotech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off level | |--------------------------------------|-----------------------------------|---------------| | Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL | | Cocaine (COC) | Benzoylecgonine | 300 ng/mL | | Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL | | Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL | | Morphine 2000 (MOP) | Morphine | 2000 ng/mL | | Barbiturates (BAR) | Secobarbital | 300 ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300 ng/mL | | Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL | | Methadone (MTD) | Methadone | 300 ng/mL | | Oxycodone (OXY) | Oxycodone | 100 ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25 ng/mL | | Buprenorphine(BUP) | Buprenorphine | 10ng/mL | | 2-ethylidene-1, 5-dimethyl-3, | 2-ethylidene-1, 5-dimethyl-3, | 300 ng/mL | | 3-diphenylpyrrolidine(EDDP) | 3-diphenylpyrrolidine | | | Morphine(MOP300) | Morphine | 300 ng/mL | | Propoxyphene(PPX) | Propoxyphene | 300 ng/mL | | Tri-cyclic Antidepressants (TCA) | Nortriptyline | 1000 ng/mL | The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine. This assay provides only a preliminary analytical test result. Gas Chromatography Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result. particularly when preliminary positive results are indicated.
    Device Description
    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.
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    K Number
    K142800
    Device Name
    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
    Manufacturer
    Co-Innovation Biotech Co., Ltd.
    Date Cleared
    2014-12-11

    (73 days)

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

    Co-Innovation Biotech Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid Single/Multi-drug test Cup and Rapid Single/Multi-drug test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off level | |--------------------------------------|-----------------------------------|---------------| | Marijuana (THC) | Delta-9-THC-COOH | 50ng/mL | | Cocaine (COC) | Benzolecgonine | 300ng/mL | | Amphetamine (AMP) | D-Amphetamine | 1000ng/mL | | Methamphetamine (MET) | D-Methamphetamine | 1000ng/mL | | Morphine 2000 (MOP) | Morphine | 2000ng/mL | | Barbiturates (BAR) | Secobarbital | 300ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300ng/mL | | Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500ng/mL | | Methadone (MTD) | Methadone | 300ng/mL | | Oxycodone (OXY) | Oxycodone | 100ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25ng/mL | The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine. The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
    Device Description
    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Barbiturates, Benzodiazepines, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests are performed without the use of an instrument. The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
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    K Number
    K140215
    Device Name
    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
    Manufacturer
    CO-INNOVATION BIOTECH CO., LTD.
    Date Cleared
    2014-06-16

    (139 days)

    Product Code
    DIS, DJC, DJG, DJR, JXM, LCM
    Regulation Number
    862.3150
    Why did this record match?
    Applicant Name (Manufacturer) :

    CO-INNOVATION BIOTECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: | Test | Calibrator | Cut-off level | |------------------------------------------|---------------------------------------|---------------| | Barbiturates (BAR) | Secobarbital | 300 ng/mL | | Benzodiazepines (BZO) | Oxazepam | 300 ng/mL | | Methylenedioxymethampheta<br>mine (MDMA) | 3,4-Methylenedioxymetha<br>mphetamine | 500 ng/mL | | Methadone (MTD) | Methadone | 300 ng/mL | | Oxycodone (OXY) | Oxycodone | 100 ng/mL | | Phencyclidine (PCP) | Phencyclidine | 25 ng/mL | The tests contain two formats:1) Test Cup, 2) Test Dipcard, 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. They are intended for prescription use in clinical laboratories only and not for point-of-care use. This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
    Device Description
    One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K131110
    Device Name
    ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
    Manufacturer
    CO-INNOVATION BIOTECH CO., LTD.
    Date Cleared
    2014-01-15

    (271 days)

    Product Code
    DKZ, DIO, DJC, DKN, LDJ
    Regulation Number
    862.3100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CO-INNOVATION BIOTECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Step Single/Multi-drug Test Cup Single/Multi-drug Test Dipeard are lateral flow chromatographic immunoassrys designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations: Marijuana (THC) Calibrato r · Delta-9-THC-COOH Cut-off level 50 ng/ml. Cocaine (COC) Benzoylecgonine 300 ng/ml. Amphetamine (AMP) D-Amphetamine 1000 ng/ml. Methamphetamine (MET) D-Methamphetamine 1000 ng/mL Morphine 2000 (MOP) Morphine 2000 ne/ml. The tests contain two formats: 1) Test Cup, 2) Test Dipeard. The test configuration comes with single drug sereening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for preseription use in clinical laboratories only and not for point-of-care use. These esss provide only a prefininary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is continuing the results in a certified laboratory. For a quantitative result or to confirm preliminary positive positive positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipeard Insert, a more specific alternaire method such as Gas Chromatography/Mass Spectomerry (GCMS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
    Device Description
    One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Cocaines, Marijuana, Methamphetamine,Morphine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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    K Number
    K132085
    Device Name
    ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
    Manufacturer
    CO-INNOVATION BIOTECH CO., LTD.
    Date Cleared
    2013-11-12

    (130 days)

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

    CO-INNOVATION BIOTECH CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Co-Innovation One Step HCG Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use. The Co-Innovation One Step HCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use. The Co-Innovation One Step HCG Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
    Device Description
    Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test is a rapid sandwich immunoassay device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, as an aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream . Three test formats use identical strips and each test strip in the device consists of: 1. A conjugate pad contains colloidal gold conjugated with mouse monoclonal anti-B-HCG antibody specific to the beta subunit of hCG. 2. A nitrocellulose membrane which is striped with the mouse monoclonal anti-a-HCG antibody in the test line (T line) and goat anti-mouse IgG polyclonal antibody in the control line (C line). The Cassette format has the same performance specifications as the Test Strip format. The difference is that the urine sample is dispensed by dropper onto the sample well on the cassette. The Midstream format has the same performance specifications as the Test Strip format. The difference is that the device is placed into the urine stream or dipped into the urine collection cup for 5 seconds.
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