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The Varelisa Cardiolipin IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgM antibodies against cardiolipin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).

The Varelisa Cardiolipin IgM Antibodies is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of IgM antibodies against cardiolipin in human serum or plasma. The wells of a microplate are coated with bovine cardiolipin antigen. Antibodies specific for cardiolipin present in the patient sample bind to the antigen. In a second step an enzyme labeled second antibody (Conjugate) binds to the antigenantibody complex which leads to the formation of an enzyme labeled antigen-antibody sandwich complex.

The provided text is a 510(k) summary for the Varelisa® Cardiolipin IgM Antibodies device. It describes the device's intended use, principle, and establishes substantial equivalence to a predicate device. However, it does not contain the detailed performance study results, acceptance criteria, or most of the specific information requested in your prompt.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or its provenance.
• Number of experts, their qualifications, or adjudication method for ground truth.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Details about a standalone (algorithm only) performance study.
• The type of ground truth used (beyond implying clinical correlation for the intended use).
• Sample size for the training set or how its ground truth was established.

The document focuses on establishing substantial equivalence based on:

• Laboratory equivalence: "results obtained within a comparison study analyzing positive, equivocal and negative sera," "results obtained for externally defined Calibrators," and "results obtained for samples from apparently healthy subjects (normal population)."

The intended use is described as:
"The Varelisa Cardiolipin IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of IgM antibodies against cardiolipin in serum or plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE)."

The "study" or evidence to support substantial equivalence is limited to a laboratory equivalence comparison between the modified device and the predicate device, analyzing various serum samples and calibrators. No specific performance metrics (like sensitivity, specificity, accuracy) or acceptance criteria are stated from this comparison. The document states that the "data show that the assay performs as expected from the medical literature," implying clinical relevance, but doesn't quantify this performance.

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