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    K Number
    K040660
    Device Name
    STERICHEK GLUTARALDEHYDE REAGENT STRIPS
    Manufacturer
    HACH COMPANY
    Date Cleared
    2004-11-15

    (248 days)

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

    STERICHEK GLUTARALDEHYDE REAGENT STRIPS

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

    SteriChek® Glutaraldehyde Reagent Strips provide a convenient means of testing the concentration of Glutaraldehyde in dialyzer disinfecting solutions. The test is not intended to replace microbiological tests or quantitative determinations of concentrations of stock solutions of Glutaraldehyde. The test may be used on a random sample of reprocessed dialyzers in order to document the presence of the agent during storage. SteriChek® Glutaraldehyde Reagent Strips do not measure residual levels of Glutaraldehyde

    Device Description

    The device is made up of a 0.20 inch square light red reagent pad that has been chemically treated to test the concentration of Glutaraldehyde in solutions for disinfecting dialyzers used in Hemodialysis. 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 describes the SteriChek® Glutaraldehyde Reagent Strips, a qualitative reagent strip method designed to measure Glutaraldehyde concentration in dialyzer disinfecting solutions. The regulatory submission (K040660) focuses on establishing substantial equivalence to a predicate device, the Serim™ Glutaraldehyde Test Strips.

    Here's an analysis of the requested information based on the provided text:

    1. Acceptance Criteria and Reported Device Performance

    The document does not explicitly state numerical acceptance criteria in the format of a table. However, it indicates the device's performance characteristics are based on analytical studies and that it effectively measures the pH or hydrogen ion concentration, which is the underlying mechanism for both the proposed device and its predicate.

    Acceptance Criteria (Implied)Reported Device Performance
    Qualitative Measurement of Glutaraldehyde ConcentrationThe device is a "qualitative reagent strip method to measure Glutaraldehyde solution by color change."
    Effective Measurement of pH/Hydrogen Ion Concentration"both systems [proposed and predicate] effectively measure the pH or hydrogen ion concentration."
    Equivalence to Predicate Device's Intended Use"The SteriChek® Glutaraldehyde Reagent Strips have the same intended use as the predicate device."
    No New Safety or Effectiveness Questions"The SteriChek® Glutaraldehyde Reagent Strips have no technological characteristics that raise new types of safety or effectiveness questions."

    2. Sample Size Used for the Test Set and Data Provenance

    The document states, "Assessment of The performance characteristics of SteriChek Glutaraldehyde Reagent Performance: Strips are based on analytical studies using samples of Glutaraldehyde solutions of various concentrations."

    • Sample Size for Test Set: Not specified. The document only mentions "samples of Glutaraldehyde solutions of various concentrations."
    • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Due to the nature of the device (reagent strips for chemical testing), it's highly likely to be prospective laboratory studies.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

    This information is not provided in the document. The ground truth was established by a reference method, not by human experts interpreting the device's output.

    4. Adjudication Method for the Test Set

    Not applicable. The ground truth was established by an analytical reference method for Glutaraldehyde concentration, not by human interpretation requiring adjudication.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or clinical interpretation where human readers are involved. This device is a chemical reagent strip.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

    The device itself is a standalone chemical test; therefore, its performance assessment is inherently standalone. The study evaluates the reagent strip's ability to react to Glutaraldehyde solutions. There is no "algorithm" in the modern sense as this device is a chemical indicator system.

    7. The Type of Ground Truth Used

    The ground truth for the performance assessment was established using a reference chemical assay method: "The reference method for determination of Glutaraldehyde is based on the reaction of Glutaraldehyde with hydroxylamine hydrochloride followed by titration of the released acid (Aldrich Chemical Company, "Basics Assay Method for Determination of Determination of Aldehydes and Ketones".)"

    8. The Sample Size for the Training Set

    Not applicable. The device is a chemical reagent strip. There is no machine learning "training set" in the context of this device.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no "training set" for this type of device. The chemical formulation and performance were likely developed through standard chemical and product development processes.

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