Search Results

Ask a specific question about this device

The HM-CAP™ EIA on the Aptus Automated Instrument is an in-vitro qualitative test for the detection of IgG antibodies in serum or plasma in adult symptomatic patients which is intended for professional in-vitro use as an adjunct or aid in the diagnosis of Helicobacter pylori.

Not Found

I am sorry, but the provided text does not contain the detailed study information required to answer your request, such as acceptance criteria, device performance data, sample sizes for test and training sets, data provenance, expert qualifications, or adjudication methods for a specific study. The document is an FDA 510(k) clearance letter for a medical device (APTUS Automated Application of the HM-CAP EIA Kit), which confirms that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use. It primarily focuses on regulatory aspects rather than detailed clinical study results or performance metrics. Therefore, I cannot generate the table or answer the specific questions about the study from this text.

Ask a specific question about this device