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    K Number
    K041349
    Device Name
    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
    Manufacturer
    IBL GMBH
    Date Cleared
    2004-09-24

    (127 days)

    Product Code
    CHP
    Regulation Number
    862.1260
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.

    Device Description

    Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

    AI/ML Overview

    The IBL Estradiol LIA is a luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol in saliva and serum.

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are not explicitly stated as distinct pass/fail thresholds in the provided document. Instead, the document presents performance characteristics and comparisons to established methods. The "acceptance" is implied by the FDA's substantial equivalence determination. We can infer the functional performance criteria from the reported values and comparisons.

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    Normal Ranges in SalivaEstablish distinct ranges for different physiological states.Premenopausal (n=28): Follicular phase 0.6 - 10.4 pg/mL; Mid-cycle Peak 4.5 - 21.2 pg/mL; Luteal phase 0.5 - 10.8 pg/mL.
    Postmenopausal (n=5):
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