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510(k) Data Aggregation

    K Number
    K110035
    Device Name
    INDIKO
    Manufacturer
    THERMO FISHER SCIENTIFIC OY
    Date Cleared
    2011-06-28

    (174 days)

    Product Code
    JJE,CFR
    Regulation Number
    862.2160
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    k061107
    Why did this record match?
    Device Name :

    INDIKO

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

    The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

    The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.

    Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

    Device Description

    The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.

    The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.

    Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.

    The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.

    Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Indiko Glucose (HK) system, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance CriteriaReported Device PerformancePerformance Accepted
    Method Comparisony = ax + b, where a = 1.00 ± 0.03, b = 0.00 ± 3.6 mg/dl, r ≥ 0.97, max bias at 90 mg/dl 5%y = 1.01x + 0.7, r = 1, Range: 6 - 700 mg/dlYes
    Precision (Within run)Low: CV ≤ 2.0 %
    Middle: CV ≤ 2.0 %
    High: CV ≤ 1.8 %Low: CV 0.7 %
    Middle: CV 0.6 %
    High: CV 0.8 %Yes
    Precision (Between run)Not specifiedLow: CV 0.8 %
    Middle: CV 1.2 %
    High: CV 0.6 %Yes
    Precision (Total)Low: CV ≤ 3.5 %
    Middle: CV ≤ 3.5 %
    High: CV ≤ 3.0 %Low: CV 1.6 %
    Middle: CV 1.5 %
    High: CV 1.5 %Yes
    Linearity/Measuring RangeMeasuring range: 5 - 720 mg/dl
    Maximum bias from the estimated straight line ± 2.7 mg/dl or ± 5 %.Measuring range: 5 - 720 mg/dlYes
    Limit of Blank (LoB)LoB:
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