LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122965
    Device Name
    HUMAN CAERULOPLASMIN KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-06-03

    (252 days)

    Product Code
    DDB
    Regulation Number
    866.5210
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HUMAN CAERULOPLASMIN KIT

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

    The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used 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 required to answer your request. The document describes an FDA 510(k) clearance letter for a "Human Ceruloplasmin Kit for use on SPAPLUS," outlining its intended use and regulatory classifications. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

    Specifically, the document lacks:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
    6. Information about standalone (algorithm-only) performance.
    7. The type of ground truth used.
    8. The sample size for the training set.
    9. How the ground truth for the training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1