LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253957

    Validate with FDA (Live)

    Device Name
    HemosIL Silica Clotting Time
    Manufacturer
    Instrumentation Laboratory (IL) Co.
    Date Cleared
    2026-01-09

    (30 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Type
    Special
    Panel
    Hematology
    Age Range
    All
    Reference & Predicate Devices
    K160445
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

    Device Description

    SCT Screen and SCT Confirm are reagents intended to simplify and standardize the detection of LA in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times.

    Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors. Using a ratio of screen and confirm allows the SCT to be insensitive to warfarin treated samples. As a result, SCT Screen and SCT Confirm are more specific tests for the evaluation of LA than APTT or dilute PT. Per CLSI Guideline H-60, patient samples containing heparin may exhibit falsely prolonged clotting times which could lead to incorrect results.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1