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510(k) Data Aggregation

    K Number
    K982217
    Device Name
    AC/AD LINEARITY VERIFIERS
    Date Cleared
    1998-07-02

    (8 days)

    Product Code
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SC CALIBRATORS **& CONTROLS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AC/AD Linearity Verifiers are intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of therapeutic drugs. AC/AD Linearity Verifiers should be used any time it is necessary to confirm the proper callbration and linear operating range of TDM methods and instruments. Quality control/verification requirements should be determined in conformance with local, state and/or Federal regulations or accreditation requirements
    Device Description
    medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). AC/AD Linearity Verifiers is a five level, multiconstituent set of calibrators made in human serum and used to confirm the proper calibration, linear operating range and reportable range (linearity) of TDM methods. The "AC/AD" designation derives from AntiConvulsant, antiAnxiety and other Qrugs. AC/AD Linearity Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level 5 has a concentration near the upper limit of instruments. Levels 1, 2, 3, and 4 are related by linear dilution. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included.
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    K Number
    K973790
    Device Name
    ABC LINEARITY VERIFIERS
    Date Cleared
    1997-10-14

    (8 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SC CALIBRATORS **& CONTROLS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ABC Linearity Verifiers is intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of selected therapeutic drugs. ABC Linearity Verifiers should be used any time it is necessary to confirm the proper calibration ind linear operating range of TDM methods and instruments. The Clinical Laboratory Improvenent Act and its regulations (CLIA) require verification of timearity and calibration twice a year for modified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new reagent lot, major preventative maintenance or replacement of critical parts on the instrument, when control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory's schedule of verification is more frequent.
    Device Description
    ABC Linearity Verifiers is an in vitro diagnostic medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). ABC Linearity Verifiers is a five level set of verifiers, with each level containing 12 analytes, is made with human serum and is used to confirm the proper callbration, linear operating range and reportable range (linearity) of TDM methods. The "ABC" designation derives from Antibiotic and Cardiac drugs. ABC Linearity Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level, and level 5 has concentrations near the upper limit of instruments. Levels 1, 2, 3, and 4 are related by linear dilution. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included.
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    K Number
    K973791
    Device Name
    ABC CALIBRATION VERIFIERS
    Date Cleared
    1997-10-14

    (8 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    **SC CALIBRATORS **& CONTROLS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ABC Calibration Verifiers is intended to be used to verify the calibration, linear operating range and reportable range (linearity) of methods used to determine the concentration of therapeutic drugs. ABC Calibration Verifiers should be used any time it is necessary to confirm the proper calibration and linear operating range of TDM methods and instruments. The Clinical Laboratory Improveent Act and its requlations (CLIA) require verification of linearity and calibration twice a year for wodified moderately complex methods, highly complex methods and in-house methods. Verification should be performed more often if any of the following occurs: introduction of procedures for which control values change with a new readent lot, major preventative maintenance or replacement of critical parts on the instrument, control values exhibit an unusual trend or shift or are outside the acceptable limits of the laboratory, and if the laboratory's schedule of verification is more frequent.
    Device Description
    ABC Calibration Verifiers is an in vitro diagnostic medical device intended for use with automated and manual methods monitoring selected therapeutic drugs (TDM). ABC Calibration Verifiers is a five level set of verifiers, with each level containing 12 analytes, is made with human serum and is used to confirm the proper calibration, linear operating range and reportable range (linearity) of TDM methods. The "ABC" designation derives from Antibiotic and Cardiac drugs. ABC Calibration Verifiers contains concentrations of analytes extending over a wide analytical range. Level 1 is a zero level, and level 5 has concentrations near the upper limit of instruments. Levels 2, 3, and 4 are targeted to be near analyte concentrations of clinical interest. When assayed like patient samples, the verifiers assist in determination of calibration and linear operating range (linearity) of methods for the analytes included. (A second product, ABC Linearity Verifiers, is identical in every respect to this product except that the concentrations of levels 1.2.3, and 4 are related by linear dilution. Both products will perform linear range and calibration verification, and their composition, stabilities and performance are identical except for concentration of middle levels.)
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