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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?
    Applicant Name (Manufacturer) :

    BIOCHEMICAL DIAGNOSTICS, INC

    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?
    Applicant Name (Manufacturer) :

    BIOCHEMICAL DIAGNOSTICS, INC

    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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