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510(k) Data Aggregation

    K Number
    K112910
    Device Name
    AP 72OS SEMI-AUTOMATED INSTRUMENT
    Manufacturer
    HITACHI CHEMICAL DIAGNOSTICS, INC.
    Date Cleared
    2012-12-20

    (444 days)

    Product Code
    DHB
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AP 720S™ Semi-Automated Instrument is a semi-automated processor for use with the OPTIGEN® Assay. The OPTIGEN® Assay is an in vitro diagnostic test for use in the semi-quantitative determination of circulating allergen-specific IgE concentrations in human serum. It is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The device is designed for use in clinical laboratories.

    Device Description

    The AP 720S™ Semi-Automated Instrument is a semi-automated processor for use with the OPTIGEN® Assay.

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA. It does not contain the detailed study information, acceptance criteria, or performance data you are requesting. This letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines regulatory responsibilities.

    To provide the information you're looking for, I would need access to the actual 510(k) submission or a summary of its contents, which typically includes the performance data and details of the clinical or analytical studies conducted.

    Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text.

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