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510(k) Data Aggregation

    K Number
    K193051
    Device Name
    LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
    Manufacturer
    DiaSorin Inc.
    Date Cleared
    2020-01-29

    (89 days)

    Product Code
    LSR,QCH
    Regulation Number
    866.3830
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K113397
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LIAISON® Lyme Total Antibody Plus: The LIAISON® Lyme Total Antibody Plus assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma (K2-EDTA, Li-heparin) samples. This assay is intended for use on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Lyme Total Antibody Plus assay should not be used to exclude Lyme disease. The test has to be performed on the LIAISON® XL Analyzer.

    The LIAISON® Lyme Total Antibody Plus Control Set: The LIAISON® Lyme Total Antibody Plus Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Lyme Total Antibody Plus assay. The performance characteristics of LIAISON® Lyme Total Antibody Plus Control Set have not been established for any other assays or instrument platforms different from the LIAISON® XL.

    Device Description

    The method for qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the Analyzer. The principal components of the test are magnetic particles (solid phase) coated with recombinant Borrelia antigens and a conjugate reagent containing two mouse monoclonal antibodies (anti- human IgG and anti-human IgM) linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, antigen-specific antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the conjuqates react with Borrelia burgdorferi IgG and IgM antibodies captured by the solid phase. Unbound material is removed with a wash cycle following incubations. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of Borrelia burgdorferi antibodies present in calibrators, samples or controls.

    AI/ML Overview

    The provided text describes the performance data for the DiaSorin LIAISON® Lyme Total Antibody Plus assay. Here's a breakdown of the acceptance criteria and study details based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data that supports the claim of substantial equivalence to a predicate device. The implied acceptance criteria are that the new device's performance is comparable to or better than the predicate device across various metrics.

    However, we can infer some "performance targets" from the "First Tier Percent Agreement with Predicate Device" and "Second Tier Testing" tables.

    Performance MetricImplied Acceptance Criteria (Goal)Reported Device Performance (LIAISON® Lyme Total Antibody Plus)
    First Tier Agreement:
    Positive % Agreement (with Predicate)High agreement with predicate for positive/equivocal results.56.5% (65/115) with 95% Cl: 47.4% - 65.2%
    Negative % Agreement (with Predicate)Very high agreement with predicate for negative results.98.7% (1416/1435) with 95% Cl: 97.9% - 99.2%
    Second Tier Testing (PPA):
    Positive Percent Agreement (with WB)High agreement with Western Blot for predicate-positive/test-positive cases97.9% (47/48) with 95% Cl: 89.1%-99.6%
    CDC Lyme Reference Sera Agreement:
    Stage I Acute AgreementHigh agreement with CDC classification.76.9% (30/39) with 95% CI: 61.7% - 87.4% (Same as Predicate)
    Stage II Convalescent AgreementHigh agreement with CDC classification.93.5% (29/31) with 95% CI: 79.3% - 98.2% (Same as Predicate)
    Stage III Late AgreementVery high agreement with CDC classification.100.0% (20/20) with 95% CI: 83.9% - 100.0% (Same as Predicate)
    Look-alike Diseases AgreementHigh negative agreement (low false positives).95.6% (86/90) with 95% CI: 89.1% - 98.3%
    Healthy Controls AgreementVery high negative agreement (low false positives).98.0% (98/100) with 95% CI: 93.0% - 99.4%
    Precision (Total %CV):Low variability across runs, days, and operators (lower is better).
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