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510(k) Data Aggregation

    K Number
    K220085
    Device Name
    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    Manufacturer
    KRONUS, Inc.
    Date Cleared
    2023-08-24

    (590 days)

    Product Code
    OIF
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
    Device Description
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    K Number
    K180607
    Device Name
    Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
    Manufacturer
    KRONUS, Inc.
    Date Cleared
    2018-11-23

    (261 days)

    Product Code
    PCG
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
    Device Description
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    K Number
    K171731
    Device Name
    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    Manufacturer
    Kronus, Inc.
    Date Cleared
    2018-01-19

    (221 days)

    Product Code
    OIF
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kronus, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.
    Device Description
    Not Found
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    K Number
    K161951
    Device Name
    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    Manufacturer
    KRONUS, INC.
    Date Cleared
    2016-07-22

    (7 days)

    Product Code
    PNI
    Regulation Number
    866.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum. The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is not to be used in conjunction with other clinical, laboratory, and radiological (e.g. MRI) findings.
    Device Description
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    K Number
    DEN150030
    Device Name
    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    Manufacturer
    KRONUS, INC.
    Date Cleared
    2016-04-25

    (298 days)

    Product Code
    PNI
    Regulation Number
    866.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    KRONUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is for the semiquantitative determination of autoantibodies to Aquaporin-4 in human serum. The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is not to be used alone and is to be used in conjunction with other clinical, laboratory, and radiological (e.g., MRI) findings.
    Device Description
    The KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay consists of ELISA strip wells coated with human recombinant AQP4 protein (amino acid position: 23-323) (96 wells in total) and supplied as 12 strips of 8 wells in a frame and sealed in a foil pouch with desiccant; ready-to-use 5 levels of calibrators (1.5, 5, 20, 40, and 80 U/mL), 5 x 0.7 mL; a ready-to-use positive (2 x . 7 mL) and a negative control serum (1 x 0.7 mL); AQP4-Biotin (lyophilized), 3 x 1.5 mL (reconstituted); ready-to-use reconstitution buffer for AQP4-Biotin, 1 x 10 mL; Streptavidin Peroxidase (SA-POD dilute before use) 1 x 0.8 mL; ready-to-use diluent for SA-POD, 1 x 15 mL; ready-to-use peroxidase substrate (TMB), 1 x 15 mL; concentrated wash solution (dilute 1:10 with deionized water before use), 1 x 120 mL and ready-to-use stop solution, 1 x 14 mL.
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