Search Results

For the quantitative determination of iron in serum. For IN VITRO diagnostic use.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Serum Iron-SL Assay." This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to previously marketed devices.

Therefore, the input does not contain the detailed information necessary to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies for a medical device. These details would typically be found in a clinical study report or a more comprehensive submission document, not in the FDA clearance letter itself.

The document only provides:

• Device Name: Serum Iron-SL Assay
• Indications For Use: For the quantitative determination of iron in serum. For IN VITRO diagnostic use.
• Regulatory Class: II

Without a study report, I cannot complete the requested tables and descriptions.

Ask a specific question about this device