LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070207
    Device Name
    MULTI-ANALYTE CHEMISTRY CALIBRATOR
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2007-04-13

    (81 days)

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

    MULTI-ANALYTE CHEMISTRY CALIBRATOR

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

    The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Multi-Analyze Chemistry Calibrator. This document approves the device based on its substantial equivalence to a legally marketed predicate device.

    It is crucial to understand that this document does not contain information about the performance or acceptance criteria of a diagnostic imaging AI device. Instead, it concerns an in-vitro diagnostic (IVD) calibrator product. Therefore, the details requested in the prompt, such as "test set," "ground truth," "MRMC study," "human readers improve with AI," and "standalone algorithm performance," are not applicable to the content provided.

    The document discusses regulatory approval for a calibrator, not a device that analyzes images or medical data for diagnosis using AI.

    As such, I cannot extract the requested information as it is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1