LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964693
    Device Name
    ELECSYS FSH ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-12-16

    (24 days)

    Product Code
    CGJ
    Regulation Number
    862.1300
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K900763
    Why did this record match?
    Device Name :

    ELECSYS FSH ASSAY

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

    Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone in human serum and plasma.

    Device Description

    Sandwich principle. Total duration of assay: 18 minutes.
    • 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex.
    •2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
    **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)) 2+ 3
    •The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
    •Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Elecsys® FSH Assay, focusing on acceptance criteria and study details.

    This document describes a medical device, specifically an in vitro diagnostic (IVD) device. For IVDs, "acceptance criteria" often refer to performance characteristics that demonstrate the device is substantially equivalent to a predicate device and performs reliably. "Device performance" is typically reported through various analytical and sometimes clinical studies.

    It's important to note that the provided text is a 510(k) summary, which is a submission to the FDA. It summarizes the information and doesn't always contain the full detail of the underlying studies.

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Metric (Unit)Predicate Device (Enzymun® FSH Assay) PerformanceElecsys® FSH Assay Performance (Reported Device)
    Precision%CV (Within-Run & Total)Low: 2.1% (Within-Run), 2.3% (Total)Low: 1.75% (Within-Run), 5.26% (Total)
    Mid: 1.8% (Within-Run), 2.6% (Total)Mid: 1.95% (Within-Run), 3.69% (Total)
    High: 1.2% (Within-Run), 3.1% (Total)High: 1.80% (Within-Run), 5.08% (Total)
    Lower Detection LimitConcentration (mIU/mL)0.50 mIU/mL0.10 mIU/mL
    LinearityRange (mIU/mL)0.50-150 mIU/mL (±10% deviation)0.10-200 mIU/mL (±10% deviation)
    Method ComparisonCorrelation Coefficient (r)0.993 (Least Squares)0.998 (Least Squares and Passing/Bablok)
    Slope (y=mx+b)0.96 (Least Squares)1.10 (Least Squares), 1.09 (Passing/Bablok)
    Interfering SubstancesBilirubin (mg/dL)No interference at 64.5 mg/dLNo interference at 25 mg/dL
    Hemoglobin (g/dL)No interference at 1 g/dLNo interference at 1 g/dL
    Lipemia (mg/dL)No interference at 1250 mg/dLNo interference at 1500 mg/dL
    Biotin (ng/mL)No interference at 90 ng/mLNo interference at 30 ng/mL
    Rheumatoid Factor (IU/mL)No interference (specific value not given)No interference at 1500 IU/mL
    Specificity (Cross-reactivity)LH (% cross-reactivity)0.00% (at 1040 mIU/mL)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1