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510(k) Data Aggregation

    K Number
    K141100
    Device Name
    OPTILITE C1 INACTIVATOR KIT
    Manufacturer
    THE BINDING SITE GROUP LTD
    Date Cleared
    2014-07-18

    (80 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTILITE C1 INACTIVATOR KIT

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

    The Optilite Cl Inactivator Kit is intended for the quantitative in vitro measurement of human C1 Inactivator in human serum using the Binding Site Optilite analyser. Measurement of CI inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Optilite C1 Inactivator and an Indications for Use statement. It confirms the device's substantial equivalence to a predicate device but does not detail the specific performance acceptance criteria or the study design and results (sample sizes, ground truth establishment, expert qualifications, etc.) that would demonstrate the device meets those criteria.

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