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510(k) Data Aggregation

    K Number
    K040226
    Device Name
    WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2004-03-25

    (52 days)

    Product Code
    JIT,JJX
    Regulation Number
    862.1150
    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 Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin Test System to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma.
    The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets those criteria. The document is primarily an FDA 510(k) clearance letter for the "Wako Prealbumin Calibrator Set" and "Wako Prealbumin Control Set", stating that the devices are substantially equivalent to legally marketed predicate devices.

    The letter mentions:

    • Trade/Device Name: Wako Prealbumin Calibrator Set, Wako Prealbumin Control Set
    • Regulation Number: 21 CFR 862.1150
    • Regulation Name: Calibrator
    • Regulatory Class: Class II
    • Product Code: JIT, JJX
    • Indications for Use:
      • Wako Prealbumin Calibrator Set: To establish points of reference for determining prealbumin values in human serum or plasma within the Wako Prealbumin Test System.
      • Wako Prealbumin Control Set: To estimate test precision and detect systematic analytical deviations in the Wako Prealbumin Test System.

    However, it does not include details on specific performance characteristics, acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. These details are typically part of the 510(k) submission itself, which is not fully provided here.

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