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510(k) Data Aggregation

    K Number
    K984074
    Device Name
    ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
    Manufacturer
    BIO-RAD
    Date Cleared
    1998-11-20

    (4 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K950469
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Architect Total T4 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System

    Device Description

    Architect Total T4 MasterCheck Level 0 contains human serum Architect Total T4 MasterCheck Levels 1, 2 and 3 contain T4 prepared in human serum. Preservative: Sodium Azide.

    AI/ML Overview

    This document is a 510(k) summary for the Bio-Rad Architect Total T4 MasterCheck, a device intended for verifying sensitivity, calibration linearity, and reportable range on the Abbott Architect i System. It claims substantial equivalence to the Casco Standards Document Serum Multi-Analyte Verification Test Set. However, the provided text does not contain any information regarding acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for device performance evaluation.

    Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study that proves the device meets them based only on the provided input. The document is primarily focused on describing the device, its intended use, and its substantial equivalence to a predicate device for regulatory purposes.

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