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Enzyme linked immunosorbent assay method for the detection of IgG, IgM and IgA autoantibodies to cardiolipin in human serum.

Uses:

The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

The assay may be used on the Hycor Hy•Tec Automated EIA instrument.

For in vitro diagnostic use only.

Not Found

I apologize, but the provided text from the FDA 510(k) K993085 document for the Autostat™II ACA Screen ELISA does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, and performance metrics.

The document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device. It defines the "Indications for Use" but does not delve into the validation studies or specific performance characteristics that led to this clearance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present in the clearance letter. Such details would typically be found in the manufacturer's 510(k) submission, which is not provided here.
2. Sample size used for the test set and data provenance: Not available.
3. Number of experts used to establish ground truth and their qualifications: Not available. The device is for in vitro diagnostic use, and ground truth would likely be established through a combination of clinical diagnosis and confirmation with other established laboratory methods, but specific details of this process are not in the document.
4. Adjudication method for the test set: Not available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: This is an in vitro diagnostic device (ELISA assay), not an imaging device or AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable in this context.
6. Standalone performance (algorithm only without human-in-the-loop performance): This is an in vitro diagnostic device and its performance is inherently "standalone" in the sense that it provides a quantitative or qualitative result without human interpretation beyond reading the result. However, the specific metrics of its standalone performance (e.g., sensitivity, specificity) are not detailed here.
7. Type of ground truth used: General indication that it's an "aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome," implying clinical diagnoses and potentially other lab tests, but no specific ground truth methodology is described.
8. Sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

This document serves as an official confirmation of regulatory clearance based on a submission that would have contained all of the study details you are asking about, but those details are not part of the clearance letter itself.

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