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The test is for the semi-quantitative combined detection of IgG, IgM and IgA autoantibodies specific for the Phospholipid Cardiolipin in huma serum or plasma (EDTA, citrate, heparin). The kit is intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus or other lupus like disorders. Total anti-Cardiolipin levels represent one parameter in a multi-criterion diagnostic process.

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The provided document is a 510(k) summary for the Axis-Shield DIASTAT™ Total Anti-Cardiolipin device and primarily focuses on regulatory approval and indications for use. It does not contain information about acceptance criteria, study design, or performance metrics in the detail requested. Therefore, I cannot fulfill your request using only the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication method for the test set.
• Information about MRMC comparative effectiveness studies or effect sizes.
• Information about standalone algorithm performance.
• Details on the type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing based on the indications for use provided. It does not elaborate on the specific studies conducted to demonstrate its performance against predefined acceptance criteria.

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