LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083518
    Device Name
    ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2009-03-13

    (107 days)

    Product Code
    JPA,DAP,GGN
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K891385,K040882,K073377,K070927,K972696
    Why did this record match?
    Reference Devices :

    K891385, K040882

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

    ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
    HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].
    HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.

    Device Description

    ACL AcuStar: The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in blood samples by: Subjecting the blood sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to allow the reactants to bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample.

    HemosIL AcuStar D-Dimer: The HemosIL AcuStar D-Dimer assay is a two-step immunoassay to quantify D-Dimer in human citrated plasma using magnetic particles as solid phase and a chemiluminescent detection system. In the first step, sample, anti-D-Dimer antibody coated magnetic particles, and assay buffer are combined, and the fibrin soluble derivatives containing the D-Dimer domain present in the sample bind to the anti-D-Dimer antibody coated magnetic particles. After magnetic separation and washing, an anti-XDP antibody labeled with isoluminol is added and incubated in a second step. After a new magnetic separation and washing, two triggers are added and the resulting chemiluminescent reaction is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the D-Dimer concentration in the sample. The ACL AcuStar D-Dimer assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined lot dependent, and is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator plastic tube barcodes.

    HemosIL AcuStar D-Dimer Controls: The Low, High, and Very High D-Dimer Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the ACL™ AcuStar™ HemosIL™ AcuStar™ D-Dimer, based on the provided 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific MetricAcceptance Criterion (Implicit)Reported Device Performance
    PrecisionCoefficient of Variation (CV%) for D-Dimer Controls and Calibrator 1The document does not explicitly state numerical acceptance criteria for precision (e.g., CV%
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1