Search Results

The sole indication for Multi-Test II is for the percutaneous administration of diagnostic allergenic extracts.

Not Found

I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study that proves the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for the "Multi-Test II" device, classifying it as a Class II hypodermic single lumen needle used for the percutaneous administration of diagnostic allergenic extracts.

This document confirms the device's regulatory classification and that it is substantially equivalent to devices marketed before May 28, 1976. However, it does not include any information about performance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance characteristics.

The letters explicitly state:

• "Please note that the 510(k) submission was not re-reviewed." (Page 0)
• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... " (Page 1)

This implies that the FDA's decision was based on a comparison to a predicate device, not necessarily on a detailed presentation of new performance study data against specific acceptance criteria in the provided document. To find the information requested, I would need access to the actual 510(k) submission document, which would typically contain such study details.

Ask a specific question about this device