LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020945
    Device Name
    AXSYM INTACT PTH, MODEL 2G06
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    2002-05-31

    (67 days)

    Product Code
    CEW,JIT,JIX
    Regulation Number
    862.1545
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K896294
    Why did this record match?
    Reference Devices :

    K896294

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

    AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

    Device Description

    AxSYM® I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM® I PTH assay uses paired monoclonal and polyclonal antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.

    AI/ML Overview

    The provided text does not contain a study that proves the acceptance criteria of the device. Instead, it details the substantial equivalence of the "AxSYM Intact PTH" device to a predicate device, the "DSL-8000 ACTIVE™ Intact PTH IRMA," through method correlation and comparison of various performance characteristics.

    Therefore, the following points address the questions based on the information available regarding the substantial equivalence study, rather than a study specifically proving acceptance criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria in this context are not explicitly stated numerical targets for device performance, but rather the demonstration of "substantial equivalence" to a predicate device. This is primarily shown through method correlation and comparable performance characteristics.

    FeatureAcceptance Criteria (Implied by Predicate Performance / Substantial Equivalence Goal)Reported AxSYM® I PTH Performance
    Method CorrelationVery high correlation (r value close to 1) between AxSYM® I PTH and predicate device.r = 0.97 (p
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1