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510(k) Data Aggregation

    K Number
    K182012
    Device Name
    ADVIA Centaur Calcitonin (CALCT) assay
    Manufacturer
    Axis-Shield Diagnostics Limited
    Date Cleared
    2018-12-21

    (147 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measuremt of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
    Device Description
    The ADVIA Centaur CALCT Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CALCT Lite Reagent and Solid Phase reagent, and one set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each). ADVIA Centaur CALCT Calibrator Assigned Value Card and barcode labels and ADVIA Centaur CALCT Master Curve Card are also included in the kit. The ADVIA Centaur CALCT assay is a fully automated, two-step immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium- ester-labeled recombinant antibody as the Lite Reagent. The Solid phase consists of anti-calcitonin mouse monoclonal antibody-coated paramagnetic microparticles.
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    K Number
    K132828
    Device Name
    ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2013-12-04

    (86 days)

    Product Code
    JKR, JIT, JJY
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elecsys Calcitonin Immunoassay: The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings. Elecsys Calcitonin CalSet: Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers. Elecsys Calcitonin CalCheck 5: The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analvzers. Elecsys PreciControl Varia: The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
    Device Description
    The Calcitonin Assay employs monoclonal antibodies specifically directed against hCT. The antibodies labeled with a ruthenium complex and biotin, respectively consist of mouse-specific components. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code. The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620. The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620. The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (k111506), with added calcitonin analyte.
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    K Number
    K060578
    Device Name
    CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2006-08-30

    (177 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
    Device Description
    Calcitonin Immunoradiometric Assay (IRMA) (Coated Tube Version)
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    K Number
    K023304
    Device Name
    IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    2002-12-09

    (67 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMMULITE/IMMULITE 1000 Calcitonin: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. IMMULITE 2000 Calcitonin: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
    Device Description
    IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin are solid-phase, chemiluminescent enzyme immunoassays for use with their respective IMMULITE/IMMULITE 1000 and IMMULITE 2000 Automated Analyzers.
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    K Number
    K990073
    Device Name
    CALCITONIN
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1999-05-11

    (120 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. This assay is intended for in vitro diagnostic use only.
    Device Description
    Calcitonin ELISA Test Kit
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    K Number
    K982491
    Device Name
    SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    1998-09-03

    (48 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is the quantitative determination of Calcitonin in human serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
    Device Description
    Quantitative determination of Calcitonin in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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    K Number
    K964635
    Device Name
    NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    1997-05-21

    (183 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961043
    Device Name
    SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    1996-05-06

    (53 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Product Code :

    JKR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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