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510(k) Data Aggregation

    K Number
    K993441
    Device Name
    K-ASSAY ALPHA-1 AG
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-24

    (43 days)

    Product Code
    LKL
    Regulation Number
    866.5420
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY ALPHA-1 AG

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

    The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. FOR IN VITRO DIAGNOSTIC USE.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "K-ASSAY Alpha-1 AG." This document outlines the regulatory approval for an in vitro diagnostic device and does not contain information about acceptance criteria or specific study results that would typically be associated with an AI/ML-driven device.

    Therefore, I cannot fulfill your request as the necessary information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) is not present in the provided text.

    The document states:

    • Device Name: K-ASSAY Alpha-1 AG.
    • Intended Use: "The K-ASSAY Alpha-1 AG Assay is intended to be used for the quantitative determination of Alpha-1 AG in human serum by immunoturbidimetric assay. Measurement of Alpha-1 AG may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes. FOR IN VITRO DIAGNOSTIC USE."
    • Regulatory Clearance: Substantial equivalence to a predicate device.

    To address your request, I would need a document that describes the clinical performance study of a device, usually found in a clinical study report or a 510(k) summary for devices that rely on quantitative or qualitative performance metrics against defined acceptance criteria.

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