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510(k) Data Aggregation

    K Number
    K960875
    Device Name
    KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-09-10

    (190 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K932822,K863920
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.

    Device Description

    The Amelung KC 40 Micro Coagulation Analyzer is an automated random access multipurpose analyzer. The KC 40 can be used for the detection of fibrin formation utilizing mechanical principles (ball method) to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KC 40 Micro Coagulation Analyzer:

    This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. The "acceptance criteria" are implied by the comparison studies, where strong correlation and acceptable coefficients of variation indicate performance similar to existing, approved devices.

    Acceptance Criteria and Reported Device Performance

    Given the nature of the 510(k) submission, the "acceptance criteria" are not explicitly stated as distinct thresholds but are inferred from the comparison study results, demonstrating equivalence to predicate devices. The reported device performance is presented as regression statistics (r-values, slope, intercept) and coefficients of variation (CV%).

    ParameterImplied Acceptance Criterion (e.g., strong correlation, low CV)Reported Device Performance (vs. TOA CA-5000)Reported Device Performance (vs. BBL Fibrometer)Precision (Coefficient of Variation)
    PTStrong correlation, acceptable precisionr = 0.980, y = 1.123x + 0.616r = 0.980, y = 1.009x + 0.701
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