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510(k) Data Aggregation

    K Number
    K123127
    Device Name
    VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2013-06-14

    (253 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VALIDATE PSA Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: Total prostate-specific antigen (PSA) and free prostate-specific antigen (fPSA) on automated systems.
    Device Description
    Quality control material (assayed and un-assayed)* Each VALIDATE® PSA Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
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    K Number
    K113524
    Device Name
    VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2012-01-27

    (59 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VALIDATE® VIT D Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range for the following analyte: total 25 (OH) vitamin D (VIT D).
    Device Description
    Each VALIDATE® VIT D Calibration / Linearity Test Kit contains purified chemicals in a human serum base. Multiple levels are provided to establish the relationship between theoretical and actual performance of each of the included analytes.
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    K Number
    K103271
    Device Name
    MSC LIPID CONTROL
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2011-01-25

    (81 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSC Lipid Control is intended for use as an assayed quality control material to monitor the ongoing precision of clinical laboratory systems for the following analytes: High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein AI (Apo AI), and Apolipoprotein B (Apo B), on instruments listed in the value sheet.
    Device Description
    The MSC Lipid Control is a human serum based liquid quality control containing stabilized HDL-C, LDL-C, CHOL, TRIG, Apo AI, and Apo B of human origin.
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    K Number
    K091225
    Device Name
    VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2009-06-25

    (59 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Validate® GC Calibration Verification / Linearity Test Sets are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual chemistry systems. See attached Package Insert labeling for all analytes claimed.
    Device Description
    VALIDATE® GC Calibration Verification / Linearity Test Sets are human and aqueous based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.
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    K Number
    K090475
    Device Name
    VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2009-04-16

    (51 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual chemistry systems. Each VALIDATE® CM2 Calibration Verification / Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-1, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.
    Device Description
    Quality control material (assayed and unassayed). VALIDATE® CM2 Calibration / Linearity Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.
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    K Number
    K083891
    Device Name
    VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2009-03-23

    (84 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Each VALIDATE® THY Calibration Verification / Linearity Test Set consists of two sets of bottles, a THY Set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4. VALIDATE® THY Calibration / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi automated, and manual chemistry systems.
    Device Description
    Quality control material (assayed and un-assayed) VALIDATE®THY Calibration Verification Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of Levels 1 through 5. One bottle of Base Matrix is also included. There exists a linear relationship among Levels 1 through 5.
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    K Number
    K082067
    Device Name
    MSC LIPID CONTROL
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2008-08-22

    (31 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.
    Device Description
    The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin.
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    K Number
    K072246
    Device Name
    VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2007-09-14

    (32 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VALIDATE® SP1 Calibration Verification Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi-automated and manual chemistry systems for the following analytes: Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Complement C3 (C3), Complement C4 (C4), c1-Antitrypsin (AAT), and Transferrin (TRF).
    Device Description
    VALIDATE® SP1 Calibration Verification Test Sets are human serum calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of five (5) levels. Each bottle of Levels 1 through 5 contains 1.0 milliliter. There exists a linear relationship between Levels 1 through 5.
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    K Number
    K062501
    Device Name
    VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2006-09-29

    (35 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.
    Device Description
    VALIDATE Thyroid Calibration Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of six (6) levels including zero. Each bottle of Levels 0 through 5 contains 3.0 milliliters. There exists a linear relationship among each set of solutions.
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    K Number
    K053247
    Device Name
    VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET
    Manufacturer
    MAINE STANDARDS CO.
    Date Cleared
    2006-01-13

    (53 days)

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

    MAINE STANDARDS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VALIDATE® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin.
    Device Description
    VALIDATE Cardiac Markers Calibration Verification Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.
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