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510(k) Data Aggregation

    K Number
    K972260
    Device Name
    CS-400 COAGULATION ANALYZER SYSTEM (A1208)
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1997-10-20

    (125 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 CS-400™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

    Device Description

    The Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).

    AI/ML Overview

    The provided text describes the 510(k) summary for the Sigma Diagnostics Inc. CS-400™ Coagulation Analyzer. The acceptance criteria and the study proving the device meets them are detailed as follows:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document lists performance characteristics from comparison studies and precision studies. The comparison studies establish the device's correlation with a predicate device, while precision studies demonstrate its reproducibility.

    Test (Method)Acceptance Criteria (from comparison study with Amelung AMAX CS-190™)Reported Device Performance (r-value)Reported Device Performance (Regression Equation)Acceptance Criteria (from precision study)Reported Device Performance (Within Run CV)Reported Device Performance (Total CV)
    PT (optical)N/A (regression statistics provided to show substantial equivalence)r = 0.921y = 1.061x + 0.6≤ (implied acceptable precision)
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