Search Results

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to SS-B in human serum.

Uses:

The results of the anti-SS-B/La assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome (SS).

For in vitro diagnostic use only.

Not Found

This document is a 510(k) clearance letter for a medical device called Autostat™ II Anti-SS-B/La ELISA. It does not contain the detailed study results, acceptance criteria, or performance data that would allow me to fully answer your request.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the purpose of semi-quantitative determination of specific IgG autoantibodies to SS-B in human serum, as an aid in diagnosing autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome (SS).

To answer your questions, I would need access to the actual 510(k) submission document or a summary of its data, which is not provided in this extract. The provided text is purely the FDA's clearance notice.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information about an MRMC comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device