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510(k) Data Aggregation

    K Number
    K040181
    Device Name
    ACCESS DHEA-S REAGENT ASSAY
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2004-03-24

    (57 days)

    Product Code
    JKC, JIT
    Regulation Number
    862.1245
    Why did this record match?
    Product Code :

    JKC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative measurement of dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems. Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of Cushing's syndrome as well as in the evaluation of adrenocortical diseases, congenital adrenal hyperplasia, and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. Patients with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, with persons overall androgen contribution to the defect in this disorder. The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
    Device Description
    The Access® DHEA-S Reagent is designed for optimal performance on the Access family of Immunoassay Systems, including the Access 2, UniCel Dxl and UniCel DxC Systems. The Access Immunoassay Systems utilize a competitive binding immunoassay for quantitative analyte measurement. The Access DHEA-S Reagent is packaged in two 50-test reagent packs and is packaged separately from the associated calibrators. The Access DHEA-S Calibrators are designed for use with the Access DHEA-S Reagent for generation of the Access calibration curve on Access Immunoassay Systems. The Access calibrators are packaged in 5.0 mL bottles, one for each of six calibrator levels.
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    K Number
    K003174
    Device Name
    ELECSYS DHEA-S
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-01-17

    (99 days)

    Product Code
    JKC
    Regulation Number
    862.1245
    Why did this record match?
    Product Code :

    JKC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K973897
    Device Name
    DHEA-S
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (30 days)

    Product Code
    JKC
    Regulation Number
    862.1245
    Why did this record match?
    Product Code :

    JKC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
    Device Description
    Not Found
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    K Number
    K962895
    Device Name
    DSL DHEA-S-7
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-09-10

    (47 days)

    Product Code
    JKC
    Regulation Number
    862.1245
    Why did this record match?
    Product Code :

    JKC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
    Device Description
    The DSL C2700 DHEA-S-7 RIA kit was developed for the quantitative measurement of DHEA-S in human serum. The RIA format is a competitive binding protein assay. Radio-labeled DHEA-S competes with un-labeled DHEA-S in the serum sample for binding sites to the DHEA-S antiserum provided with the kit. Separation of free from bound DHEA-S is achieved by the centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled DHEA-S bound to the antibody is inversely proportional to the concentration of the DHEA-S present in the sample.
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    K Number
    K955114
    Device Name
    DSL AACTIVE DHEA EIA KIT
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-02-23

    (106 days)

    Product Code
    JKC
    Regulation Number
    862.1245
    Why did this record match?
    Product Code :

    JKC

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

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