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510(k) Data Aggregation

    K Number
    K033910
    Device Name
    OLYMPUS URINE CALIBRATOR
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2004-01-30

    (44 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Olympus™ Urine Calibrator is intended for use in the calibration of quantitative chemistry assays including Amylase, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Total Protein, and Urea on the Olympus™ series of chemistry analyzers.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Olympus™ Urine Calibrator, a Class II device. It primarily focuses on the device's substantial equivalence to a predicate device and its intended use for calibrating various urine chemistry assays on Olympus™ chemistry analyzers.

    However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, or expert involvement. These types of details are typically found in the more comprehensive 510(k) submission itself, not in the FDA's decision letter.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study, as this information is not present in the provided text.

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