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510(k) Data Aggregation

    K Number
    K994238
    Date Cleared
    2000-06-23

    (190 days)

    Product Code
    Regulation Number
    864.7060
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    IL TEST LIQUID ANTITHROMBIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.

    Device Description

    IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.

    This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the IL Test™ Liquid Antithrombin device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (IL Test™ Antithrombin). The key performance metrics are method comparison (correlation with the predicate) and within-run precision.

    MetricAcceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (ACL 6000)Reported Device Performance (ACL Futura)
    Method Comparison
    Slope (vs. Predicate)Close to 1.000.991.01
    Correlation Coefficient (r)Close to 1.00 (e.g., >0.95 or >0.98)0.9950.994
    Within Run Precision
    Normal Plasma % CVLow (typically
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