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510(k) Data Aggregation

    K Number
    K162395
    Device Name
    MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
    Manufacturer
    MP BIOMEDICALS, LLC
    Date Cleared
    2017-06-02

    (280 days)

    Product Code
    DIO, DIS, DJG, DJR, DKZ, JXM, LAF, LCM, LDJ
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MP BIOMEDICALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device. The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    The Rapid Diagnostics MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are competitive binding, lateral flow immunochromatographic iv-vitro assays for the qualitative and simultaneous detection of amphetamines, barbiturates, benzodiazenines, buprenorphine, cocaine, methadone, methamphetamine, opiates, oxycodone and phencyclidine, in human urine samples. MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup detects each of the analytes on separate strips. A positive urine sample will not generate a colored line for the specific drug tested in the designated region. A negative urine sample containine, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine, methamphetamine, opiates, oxycodone or phencyclidine below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored line will always appear at the control region.
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    K Number
    K051958
    Device Name
    MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
    Manufacturer
    MP BIOMEDICALS, LLC.
    Date Cleared
    2006-07-21

    (367 days)

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

    MP BIOMEDICALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml. The MP RapidOXY Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-beta-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml. The MP RapidBUP Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
    Device Description
    The MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibody and antigen to analyze particular compounds in human urine specimens. The assays rely on the competition for binding antibody between drug conjugate and free drug which may be present in urine. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibodydve conjugate. When the amount of drug is equal or more than the cut-off (i.e., 100 ng/ml oxycodone or 10 ng/ml buprenorphine-3-beta-d-glucuronide, or B-3-beta-d-G), it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control in both assays. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
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