Search Results

The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.

enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study design, and results. The document is an FDA 510(k) clearance letter for a "Helicobacter pylori IgG ELISA Test System," which indicates that the device has been found substantially equivalent to a predicate device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance.
• The number or qualifications of experts used for ground truth.
• The adjudication method.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone performance study.
• The type of ground truth used.
• How ground truth was established for the training set.

This document is primarily concerned with the regulatory clearance of the device rather than the specific details of its validation study and performance metrics.

Ask a specific question about this device

The Zeus Scientific, Inc. Helicobacter pylori IgG ELISA test System is intended for the qualitative detection of IgG antibody in symptomatic adult serum. It may or may not be indicated as an aid in the determination of serological status.

Not Found

I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria, study details, or performance metrics within the document. The text is a formal letter from the FDA regarding a 510(k) clearance for the "Helicobacter pylori IgG ELISA Test System," confirming its substantial equivalence to previously marketed devices.

This type of letter focuses on the regulatory approval and does not typically include the detailed technical performance data of the device, the study design, or the specific criteria met for that approval. These details would usually be found within the 510(k) submission document itself, which is not provided here.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or training set details.

Ask a specific question about this device