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510(k) Data Aggregation

    K Number
    K971103
    Device Name
    AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
    Manufacturer
    TOSOH MEDICS, INC.
    Date Cleared
    1997-06-27

    (93 days)

    Product Code
    KHO
    Regulation Number
    862.2560
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

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

    The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.

    Device Description

    The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.

    AI/ML Overview

    This document is a letter from the FDA regarding the 510(k) premarket notification for the AIA NexIA Automated Enzyme Immunoassay System. It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, the letter does not contain any information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses solely on the regulatory approval from the FDA, and not on the technical performance studies of the device.

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