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    K Number
    K053533
    Device Name
    IMMULITE/IMMULITE 1000 TURBO INTACT PTH
    Manufacturer
    DIAGNOSTIC PRODUCTS CORPORATION
    Date Cleared
    2006-02-03

    (46 days)

    Product Code
    CEW
    Regulation Number
    862.1545
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K992105
    Why did this record match?
    Device Name :

    IMMULITE/IMMULITE 1000 TURBO INTACT PTH

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

    For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively.

    Device Description

    IMMULITE/IMMULITE 1000 Turbo Intact PTH is a solid-phase, chemiluminescent immunometric assay employing a goat polyclonal anti-PTH (44-84) antibody as the capture antibody and a goat polyclonal anti-PTH (1-34) antibody conjugated to alkaline phosphatase as the detection antibody.

    AI/ML Overview

    Here's an analysis of the IMMULITE®/IMMULITE® 1000 Turbo Intact PTH device's acceptance criteria and the supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Used as a benchmark for intraoperative utility)Reported Device Performance
    Criterion 1: 50% or greater decrease from baseline PTH value suggests complete tumor removal.Mayo Clinic Study: 45 out of 47 patients (96%) had their plasma intact PTH (iPTH) levels decrease to 50% decrease in iPTH values.
    Criterion 2: Return to normal iPTH values after parathyroid tissue is removed (indicating clinical cure).Mayo Clinic Study: This occurred in 87% of patients, and all of them were clinically cured.
    Criterion 3: Samples suitable for intraoperative monitoring (rapid results).Mayo Clinic Study: Collection of blood samples was stopped at 10 minutes (2 patients) and 15 minutes (2 patients), suggesting results were available quickly enough for intraoperative decisions.
    Criterion 4: Comparable physiological outcomes (normocalcemia postoperatively) when using intraoperative PTH vs. traditional methods.Washington University Study: 44/49 (90%) of the study group (with intraoperative PTH) and 49/55 (89%) of the control group achieved normocalcemia postoperatively. This indicates identical physiological outcomes.
    Criterion 5: Reduced reliance on frozen section use with intraoperative PTH.Washington University Study: Frozen section use in the study group was statistically significantly less (p
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