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510(k) Data Aggregation

    K Number
    K973588
    Device Name
    LIQUID ALKALINE PHOSHATASE REAGENT SET
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1997-10-22

    (30 days)

    Product Code
    CJE
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.

    Device Description

    Liquid Alkaline Phosphatase Reagent Set

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Liquid Alkaline Phosphatase Reagent Set." It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain information about acceptance criteria, device performance studies, or details relevant to a typical AI/medical imaging device submission.

    The letter is for an in vitro diagnostic (IVD) reagent set, not an AI or imaging device. Therefore, the questions posed (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.

    To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a medical device that utilizes AI, imaging, or has a performance study section.

    Based on the provided document, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details.

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