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510(k) Data Aggregation

    K Number
    K974798
    Device Name
    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1998-03-20

    (88 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

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

    SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

    Device Description

    The device is made up of a 0.20 square inch off-white reagent pad that is chemically treated to detect peroxide in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.

    AI/ML Overview

    The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the way a typical medical device study would describe. The document is a 510(k) Safety and Effectiveness Summary for the SteriChek™ Residual Peroxide Reagent Strips.

    This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study against defined acceptance criteria.

    However, based on the information provided, we can infer some aspects and highlight what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Inferred from intended use)Reported Device Performance (Inferred/Stated)
    Detection of peroxide in waterChemically treated pad detects peroxide
    Measurement of peroxide concentrationPad changes color relative to amount of peroxide
    Ability to detect levels
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