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Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative : detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

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The document provided is a 510(k) clearance letter from the FDA for several ImmuLisa Enhanced™ Cardiolipin Antibody (ACA) ELISA tests, indicating they are substantially equivalent to legally marketed predicate devices. It does not contain details about acceptance criteria or specific study results related to the performance of these devices.

The typical content of a 510(k) clearance is an affirmation of substantial equivalence, not a detailed report of clinical study outcomes or device performance against pre-defined acceptance criteria. Therefore, most of the information requested in your prompt cannot be extracted from this document.

Here's what can be inferred or stated based on the document:

• Acceptance Criteria and Reported Device Performance: Not provided in the document. The FDA determined substantial equivalence, but the specific performance of the device or the criteria it met are not detailed here.
• Sample size used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided, as this document is a regulatory clearance, not a study report.
• Adjudication method for the test set: Not applicable or provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable or provided, as these are in vitro diagnostic (IVD) tests, not typically subject to MRMC studies in the same way as imaging algorithms.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. These are lab-based ELISA tests, not AI algorithms.
• The type of ground truth used: Not specified, as the document doesn't detail the studies. For IVDs, ground truth is typically established by reference methods, clinical diagnosis, or patient outcomes.
• The sample size for the training set: Not applicable or provided, as these are lab-based ELISA tests, not AI algorithms requiring a training set in the machine learning sense.
• How the ground truth for the training set was established: Not applicable or provided.

In summary, this document is a regulatory approval notice and does not contain the detailed scientific study information requested. To find such information, one would typically need to review the 510(k) submission itself (which is often extensive and not publicly available in its entirety) or peer-reviewed publications related to the device.

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