LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051810
    Device Name
    WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Date Cleared
    2005-09-09

    (66 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K051610
    Why did this record match?
    Device Name :

    WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014

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

    The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma and serum. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the Scantibodies Laboratory, Inc. Whole PTH Immunoradiometric (IRMA) Tube Assay. It declares the device substantially equivalent to legally marketed predicate devices.

    The information provided does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. This type of regulatory letter confirms the device's market clearance but does not typically contain the detailed technical study information that would be present in a submission's supporting data section.

    Therefore, I cannot provide the requested table and information based on the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1