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510(k) Data Aggregation

    K Number
    K000979
    Device Name
    REDI-SCREEN
    Date Cleared
    2000-04-10

    (14 days)

    Product Code
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    REDWOOD BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay for the qualitative determination of the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine at the following cut off concentrations; | THC | 50ng/mL | |-----------------|------------| | PCP | 25ng/mL | | Opiates | 300ng/mL | | Cocaine | 300ng/mL | | Methamphetamine | 1,000ng/mL | The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. This test is for use in clinical laboratories by health care and forensic professionals only.
    Device Description
    The Redi-Screen is an immunochromatographic based one step in vitro test.
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    K Number
    K993100
    Device Name
    REDI-SCREEN
    Date Cleared
    1999-10-06

    (20 days)

    Product Code
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    REDWOOD BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels: THC 50ng/mL PCP 25ng/mL Opiates 300ng/mL Cocaine 300ng/mL Methamphetamine 1,000ng/mL The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS, This test is for use in clinical laboratories by health care and forensic professionals only.
    Device Description
    The Redi-Screen is an immunochromatographic based one step in vitro test.
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    K Number
    K991698
    Device Name
    REDI-TEST PCP
    Date Cleared
    1999-08-25

    (99 days)

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

    REDWOOD BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
    Device Description
    The Redi-Test PCP is an immunochromatograpic based one step in vitro test.
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    K Number
    K991110
    Device Name
    REDI-TEST COCAINE
    Date Cleared
    1999-07-26

    (116 days)

    Product Code
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    REDWOOD BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Test Cocaine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the cocaine metabolite, benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
    Device Description
    The Redi-Test Cocaine is an immunochromatograpic based one step in vitro test.
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    K Number
    K991504
    Device Name
    REDI-TEST METHAMPHETAMINE
    Date Cleared
    1999-07-22

    (84 days)

    Product Code
    Regulation Number
    862.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    REDWOOD BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Test Methamphetamine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of d, methamphetamine at a cutoff concentration of 1000ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
    Device Description
    The Redi-Test Methamphelamine is an immunochromatographic based one step in vitro lest.
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    K Number
    K990870
    Device Name
    REDI-TEST THC
    Date Cleared
    1999-04-27

    (42 days)

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

    REDWOOD BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Redi-Test THC is designed for the qualitative determination of cannabinoids (THC) and its metabolites in human urine specimens. The presence of 11nor-Δ°-ΤΗC-9-COOH in human urine as low as 50 ng/ml can be detected. This test is for use in clinical laboratories by health care professionals and forensic professionals only. The Redi-Test THC is a rapid immunochromatographic competitive assay used to screen human urine for the presence of cannabinoids at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed by an alternate methodology preferably GC/MS.
    Device Description
    The Redi-Test THC is an immunochromatograpic based one step in vitro test.
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