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510(k) Data Aggregation

    K Number
    K971505
    Device Name
    SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-06-11

    (47 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K934046
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

    Device Description

    The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.

    AI/ML Overview

    Here's an analysis of the provided text, outlining the acceptance criteria and study details for the SYNCHRON® Systems Cholesterol (CHOL) Reagent:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for performance. Instead, it presents performance data (method comparison and imprecision) which is presumably used to demonstrate substantial equivalence to the predicate device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's and generally accepted clinical standards for cholesterol measurement.

    Performance MetricImplied Acceptance Criteria (Based on general clinical standards for cholesterol)Reported Device Performance
    Method Comparison (vs. Predicate)Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99)Slope: 0.983
    Intercept: 2.41 mg/dL
    r (correlation coefficient): 0.9996
    (Compared to SYNCHRON Systems Cholesterol (CHOL) Reagent predicate)
    Method Comparison (vs. Reference Method)Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99)Slope: 1.002
    Intercept: -2.07 mg/dL
    r (correlation coefficient): 0.9961
    (Compared to Abell-Kendall Reference Method)
    Within-Run Imprecision (Default Range)Typical CVs for cholesterol assays are generally
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