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510(k) Data Aggregation

    K Number
    K153474
    Device Name
    Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
    Manufacturer
    BIOCHEMICAL DIAGNOSTICS, INC
    Date Cleared
    2016-02-23

    (83 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. The Detectabuse® controls are designed to provide an estimation of the precision of a device test system, and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects, at levels established by SAMHSA, CAP/AACC, many state programs and device manufacturers QC requirements. The Detectabuse® control urines are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents. They should be treated as any "unknown" specimen while following the specific protocol of the assay being used. This product is intended to be used under the supervision of health care professionals as an integral part of good laboratory practices.
    Device Description
    Each bottle contains stabilized human based urine. Multi-constituent and single constituent positive control urines have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain less than 1% sodium azide as a preservative. For assays sensitive to sodium azide such as ELISA we substitute a proprietary preservative approved by the manufacturers and DEA.
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    K Number
    K132688
    Device Name
    SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
    Manufacturer
    BIOCHEMICAL DIAGNOSTICS, INC.
    Date Cleared
    2013-12-16

    (110 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salivabuse® liquid oral fluid controls are intended for in vitro diagnostic use only as quality controls to monitor the precision of laboratory oral fluid toxicology testing procedures for the analytes listed in the package insert. The Salivabuse ® controls are available as multi-constituent and single constituent controls.
    Device Description
    The Salivabuse ® multi-constituent and the Salivabuse® single constituent controls are designed to provide an estimation of the precision of a device test system, and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. Salivabuse® liquid oral fluid controls are available in Negative, Cutoff -60%, Cutoff -50%, Cutoff -30%, Cutoff -25%, Cutoff, Cutoff +2.5%. Cutoff +50%. 2X Cutoff and 3X Cutoff levels. Each bottle contains stabilized synthetic oral fluid. Positive controls have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative controls are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain either sodium azide or a proprietary preservative compatible with products that are adversely affected by sodium azide.
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    K Number
    K132174
    Device Name
    MULTICHEM WBT
    Manufacturer
    TECHNO-PATH MANUFACTURING LTD.
    Date Cleared
    2013-09-20

    (67 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multichem WBT control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.
    Device Description
    Technopath has developed whole blood control materials prepared from human whole blood, to which whole blood purified biochemical material (extracts of human origin), chemicals, drugs, preservatives and stabilizers have been added. Three levels of control are available to allow performance monitoring within the analytical range.
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    K Number
    K121122
    Device Name
    DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
    Manufacturer
    BIOCHEMICAL DIAGNOSTIC, INC.
    Date Cleared
    2012-07-03

    (81 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
    Device Description
    Not Found
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    K Number
    K121143
    Device Name
    LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
    Manufacturer
    Bio-Rad Laboratories
    Date Cleared
    2012-05-18

    (32 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    This product is prepared from human whole blood with added preservatives and stabilizers. The control is provided in liquid form for convenience. Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert. Each laboratory should establish its own means and acceptable ranges based on their own test system and tolerance limits.
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    K Number
    K120504
    Device Name
    LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Date Cleared
    2012-03-27

    (35 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology screening procedures.
    Device Description
    Liguichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.
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    K Number
    K103656
    Device Name
    THERMO SCIENTIFIC MAS R DOA TOTAL
    Manufacturer
    Microgenics Corporation
    Date Cleared
    2011-03-24

    (99 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH. MAS® DOA Total provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.
    Device Description
    DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity. DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels used by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA); for Amphetamines, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).
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    K Number
    K093577
    Device Name
    LIQUICHEK OPIATE CONTROL
    Manufacturer
    Bio-Rad Laboratories
    Date Cleared
    2010-03-12

    (114 days)

    Product Code
    DIF, REG
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
    Device Description
    Liquichek Opiate Control is prepared from human urine with added drugs of abuse, metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.
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    K Number
    K080085
    Device Name
    MAS TOX CONTROL
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2008-04-30

    (110 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAS Tox Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
    Device Description
    Not Found
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    K Number
    K080183
    Device Name
    CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2008-03-25

    (60 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DIF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information. The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information. The Control Set DAT III is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information. The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers. The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
    Device Description
    Control Set DAT I is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity. Control Set DAT I contains a mixture of 10 different drugs. Drug concentrations in are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff. Control Set DAT II is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity. Control Set DAT II contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff. Control Set DAT III is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity. Control Set DAT III contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff. Control Set Amphetamine 1000 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity. Drug concentrations in Control Set Amphetamine 1000 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff. Control Set Amphetamine 500 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity. Drug concentrations in Control Set Amphetamine 500 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
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