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510(k) Data Aggregation

    K Number
    K993496
    Device Name
    RETIC-QUINOX
    Manufacturer
    HEMATRONIX, INC.
    Date Cleared
    1999-11-30

    (46 days)

    Product Code
    JPK
    Regulation Number
    864.8625
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K930119
    Predicate For
    K042836
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.

    Device Description

    Retic-Quinox is a reference control material designed to monitor the accuracy and precision of Coulter instruments capable of performing reticulocyte counts.

    AI/ML Overview

    The provided text describes a 510(k) summary for the "Retic-Quinox Reticulocyte Control Mixture," a quality control device. However, the document does not contain explicit details about acceptance criteria, a specific study proving the device meets those criteria, or the methodology (sample size, expert qualifications, ground truth establishment, etc.) of such a study.

    The document primarily focuses on:

    • Device Description: Retic-Quinox is a reference control material for monitoring accuracy and precision of Coulter instruments performing reticulocyte counts.
    • Predicate Device Comparison: It states that both Retic-Quinox and the predicate device (Retic-C) are in vitro diagnostic controls made of stabilized human red cells and a reticulocyte-like component in a buffered fluid. Both provide three levels for monitoring.
    • Substantial Equivalence: The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying it has similar performance characteristics for its intended general use as a quality control.

    Therefore, based solely on the provided text, the specific information requested in your prompt regarding acceptance criteria, a standalone study, and its detailed methodology cannot be extracted. The document confirms the device's regulatory classification and its substantial equivalence determination but does not include the detailed performance study report you've asked for.

    If this information were available in a more comprehensive submission or study report, it would typically include a section detailing performance data against predefined acceptance criteria.

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