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510(k) Data Aggregation

    K Number
    K093137
    Device Name
    K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2010-09-28

    (358 days)

    Product Code
    NDY,JIT,JJX
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE.

    The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE.

    The K-ASSAY ® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Kamiya Biomedical Company regarding their K-ASSAY Cystatin C Assay. It mostly discusses the regulatory approval process and includes a brief "Indications for Use Statement". It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a detailed 510(k) summary.

    Therefore, I cannot extract the specific information you requested. The document does not provide:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for test sets.
    • Information about MRMC comparative effectiveness studies, effect sizes, or standalone algorithm performance.
    • Details on the type of ground truth used or how it was established.
    • Sample size or ground truth establishment for a training set.

    This document is a regulatory approval letter, not a scientific study report. To get the requested information, you would typically need to refer to the full 510(k) submission, specifically the sections detailing analytical and clinical performance studies, which are not included in this letter.

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