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510(k) Data Aggregation

    K Number
    K971203
    Device Name
    SYNCHRON SYSTEMS THYROXINE REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-05-16

    (45 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K935880,K942575
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems.

    Device Description

    The SYNCHRON Systems Thyroxine (T4) Reagent kit, which includes the T4 Reagent and the T4 Calibrators, in intended for use on Beckman's SYNCHRON Clinical Systems.

    AI/ML Overview

    Here's an analysis of the provided text regarding the SYNCHRON Systems Thyroxine (T4) Reagent, focusing on acceptance criteria and supporting studies:

    This document is a 510(k) Summary of Safety & Effectiveness for an in vitro diagnostic device, not a medical imaging AI device. Therefore, many of the requested fields (like the number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. The 'ground truth' in this context refers to the true concentration of T4 in a sample, which is established by comparison to a legally marketed predicate device.

    Acceptance Criteria and Device Performance for SYNCHRON Systems Thyroxine (T4) Reagent

    1. Table of Acceptance Criteria and Reported Device Performance

    For in vitro diagnostic devices like this, the primary acceptance criteria revolve around demonstrating equivalence to a legally marketed predicate device through method comparison, imprecision, and stability. While explicit numerical acceptance criteria are often present in the full submission, this summary provides the performance results that are implicitly compared against such criteria to demonstrate equivalence.

    Performance MetricAcceptance Criteria (Implied for Equivalence)Reported Device Performance
    Method ComparisonSlope: Close to 1.0
    Intercept: Close to 0
    Correlation Coefficient (r): High (e.g., >0.95 or >0.98)Slope: 1.018
    Intercept: 0.12 µg/dL
    r: 0.992
    Imprecision (Within-Run)%C.V. should be within acceptable limits for diagnostic assays (e.g., typically
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