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

Uses:

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

For in vitro diagnostic use only.

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This document, a 510(k) clearance letter from the FDA for the Autostat™ II Anti-SS-A/Ro ELISA, primarily focuses on regulatory approval and does not contain the detailed technical information required to answer your request about acceptance criteria, study design, and performance metrics.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. To prove substantial equivalence, manufacturers typically submit data from studies, but the specifics of those studies (like sample size, ground truth, expert involvement, etc.) are found in the 510(k) submission itself, not in the FDA's clearance letter.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about the study design elements as requested. The provided text does not contain:

1. Acceptance criteria or reported device performance.
2. Sample size for test set or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

This document is a formal notification of regulatory clearance based on a review of submitted materials, not a disclosure of the detailed scientific or clinical study reports.

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