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    K Number
    K161831
    Device Name
    IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
    Manufacturer
    Immunodiagnostic Systems Ltd
    Date Cleared
    2016-11-15

    (133 days)

    Product Code
    MRG,JJX
    Regulation Number
    862.1825
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k091849,k111650,k140554
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    Device Name :

    IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

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

    The IDS iSYS 25 VilD assay is intended for the quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in hyman serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

    The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD assay on the IDS-iSYS Multi-Discipline Automated System.

    Device Description

    The IDS-iSYS 25 VitDs reagent kit consists of one (1) Immunoassay Cartridge, one (1) vial each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

    IDS-iSYS 25 VitDS Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. IDS-iSYS 25 VitDS Cartridge contains the following ready to use reagents:

    • Magnetic particles coated with streptavidin in a phosphate . buffer containing sodium azide.
    • . Sodium hydroxide solution.
    • . 25(OH)D labelled with an acridinium ester derivative, in buffer containing bovine serum albumin with sodium azide.
    • . Anti-25(OH)D sheep polyclonal antibody labelled with an biotin, in buffer containing bovine, sheep and mouse proteins and sodium azide.
    • . Assay buffer containing proprietary displacing compounds, methanol and sodium azide.

    The IDS-iSYS 25 VitD® Calibrators are included in the reagent kit. The ready to use calibrators contains human serum buffer matrix with two defined concentrations of 25(OH)D and sodium azide as preservative (

    AI/ML Overview

    The provided document describes the IDS-iSYS 25VitD8 assay, a device for the quantitative determination of total 25-hydroxyvitamin D [25(OH)D] in human serum or plasma. Below is an analysis of its acceptance criteria and the studies performed.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a single, consolidated table. However, it presents performance data for various analytical characteristics, and in some cases, implicitly defines acceptable ranges or desired outcomes for these studies. For instance, in the specificity study, an acceptance criterion of "

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