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    K Number
    K130528
    Device Name
    BIOPLEX 2200 APLS IGM
    Manufacturer
    Bio-Rad Laboratories
    Date Cleared
    2013-10-21

    (234 days)

    Product Code
    MID,JIX,JJX,MSV
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    k092181,k091556
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    Device Name :

    BIOPLEX 2200 APLS IGM

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

    The BioPlex®2200 Antiphospholipid Syndrome (APLS) IgM kit is a multiplex flow immunoassav intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.

    The BioPlex 2200 APLS IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

    The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack.

    The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding BioPlex 2200 APLS IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 APLS IgM Control Set has not been established with any other Antiphospholipid assay.

    Device Description

    BioPlex® 2200 APLS IgM kit includes the following components:

    • o One (1) 10 mL vial of Bead Set containing two different populations of dyed beads coated with Cardiolipin (CL) and Beta-2-Glycoprotein I (B2GPI). an Internal Standard bead (ISB). a Serum Verification bead (SVB), and a Reagent Blank bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with glycerol and protein stabilizers (porcine), and ProClin 300 (
    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the BioPlex® 2200 Antiphospholipid Syndrome (APLS) IgM kit, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Precision/ReproducibilityTotal precision for Anti-Cardiolipin IgM (serum & heparin)%CV ≤ 8.1% (High Positive serum)
    Total precision for Anti-β2GPI IgM (serum & heparin)%CV ≤ 8.0% (High Positive serum)
    Lot-to-Lot ReproducibilityNot explicitly stated but implied by detailed results.For Anti-Cardiolipin IgM, Total %CV ranged from 5.6% to 11.8%. For Anti-β2GPI IgM, Total %CV ranged from 6.8% to 14.1%.
    Linearity/Assay Reportable RangeRegression parameters (slope, intercept, r²) for linearity study. Reportable range.Slopes near 1.00, intercepts near 0.00, r² > 0.99. Reportable range: Anti-Cardiolipin IgM (0.2 to 112 MPL-U/mL), Anti-β2GPI IgM (0.2 to 112 U/mL).
    Detection Limit (LoQ, LoD, LoB)Specific values for LoQ, LoD, LoB.Anti-Cardiolipin IgM: LoQ: 0.2, LoD: 0.13, LoB: 0.0974 MPL-U/mL. Anti-β2GPI IgM: LoQ: 0.2, LoD: 0.13, LoB: 0.1044 U/mL.
    Analytical Specificity (Interference)No interference observed with specified substances at maximum levels.No interference observed with: Hemoglobin (≤500 mg/dL), Bilirubin (unconjugated ≤20 mg/dL, conjugated ≤30 mg/dL), Triglycerides (≤3300 mg/dL), Total Protein (≤12 g/dL), Cholesterol (≤500 mg/dL), Red Blood Cells (≤0.4% (v/v)), Gamma-Globulin (≤6 g/dL), Beta-Carotene (≤0.6 mg/dL), Ascorbic Acid (≤3 mg/dL), Heparin Lithium (≤8000 units/dL), Heparin Sodium (≤8000 units/dL), Sodium Citrate (
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