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510(k) Data Aggregation

    K Number
    K061598
    Device Name
    HEMOSIL HOMOCYSTEINE AND CONTROLS
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2006-09-22

    (106 days)

    Product Code
    LPS,JJX
    Regulation Number
    862.1377
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K992858
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine (Hcy) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.

    HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems.

    For in vitro diagnostic use.

    Device Description

    HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine (Hcy) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.

    HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems.

    Hey levels in patient plasma are measured automatically on IL Coagulation Systems in three stages:

    1. Reduction of mixed disulfides and protein-bound forms of Hcy present in the plasma samples to free Hcy.
    2. Enzymatic conversion of free Hcy to S-adenosyl-L-homocysteine (SAH) by the SAH hydrolase (SAHH) in the presence of an excess of adenosine.
    3. Competitive agglutination reaction between anti-SAH and SAH / conjugate.

    The degree of agglutination is inversely proportional to the concentration of total Hev in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the HemosIL Homocysteine and HemosIL Homocysteine Controls, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Metric (Implicit)Acceptance Criteria (Implicit)Reported Device Performance
    Method ComparisonCorrelation with predicate device (Abbott IMx Homocysteine)Strong correlation (e.g., r > 0.95 or similar range)ACL Advance: Slope: 0.8292, Intercept: 0.3503, r: 0.9915 (for 76 paired samples with Hcy levels 4.2 to 56.7 umol/L)
    PrecisionWithin-run Coefficient of Variation (CV%)Low CV% (typically
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