Search Results

The K-ASSAY IgG Assay is intended to be used for the quantitative determination of IgG in human serum by immunoturbidimetric assay. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. FOR IN VITRO DIAGNOSTIC USE.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the K-ASSAY IgG device. It acknowledges the device's substantial equivalence to previously marketed devices for the quantitative determination of IgG in human serum.

However, this document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the specific study proving the device meets those criteria. The letter focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study report.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

To obtain this information, you would typically need access to the full 510(k) submission, specifically the performance study report and potentially the validation protocols, which are not included in this FDA clearance letter.

Ask a specific question about this device