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510(k) Data Aggregation

    K Number
    K955735
    Device Name
    KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-03-11

    (84 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Amelung KC 4 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests. Any clotting time test that has fibrin formation as its endpoint may be performed on the KC 4 A.

    Device Description

    The Amelung KC 4 A Micro Coagulation Analyzer is a semi-automated mechanical clot detection system designed for the determination of prothrombin times (PT), activated partial thromboplastin times (APTT), fibrinogen concentrations and other clotting tests.

    AI/ML Overview

    The provided text describes performance testing for the Amelung KC 4 A Micro Coagulation Analyzer, a semi-automated mechanical clot detection system. However, specific acceptance criteria are not explicitly stated in a defined table or section. Instead, the study aims to demonstrate substantial equivalence to predicate devices and acceptable precision.

    Here's an analysis of the available information:

    1. Table of "Acceptance Criteria" and Reported Device Performance

    Since explicit acceptance criteria are not provided, I will interpret "acceptable limits" for precision and strong correlation coefficients for method comparison as the implied criteria for substantial equivalence.

    Performance MetricImplied Acceptance Criterion (Inferred)Reported Device PerformanceComments
    Method Comparison (Correlation with Reference/Predicate Devices)Correlation coefficient (r) close to 1, and regression equation (y = mx + b) where m is close to 1 and b is close to 0 (indicating good agreement)See detailed results belowThe reported r values are generally high, indicating strong correlation.
    Precision"Within acceptable limits" (for beta sites); Coefficient of Variation (CV)
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