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510(k) Data Aggregation

    K Number
    K042549
    Device Name
    MULTI CHEM CAL B
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-11-08

    (49 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTI CHEM CAL B

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

    The Multi-Chem Calibrator B is designed to be used with Wako's assays to determine the points of reference that are used in the determination of Glucose, Uric Acid and Urea N in human serum.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "Multi-Chem Calibrator B," and it only lists the device name, regulation number, product code, and its intended use. It does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication methods.
    5. Information about Multi-Reader Multi-Case (MRMC) studies or effect sizes.
    6. Results from standalone (algorithm only) performance studies.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document confirms substantial equivalence, which is a regulatory decision, not a detailed performance study report.

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