Search Results

The Excelsior blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters. Excelsior test strips, when used with the Home Diagnostics, Inc. Prestige LX blood glucose meters, quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

Excelsior blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX Dood glucose system, and Prestige IQ blood glucose system.

The provided document is an FDA 510(k) clearance letter for a medical device (Excelsior Blood Glucose Test Strips). It states that the device is substantially equivalent to a legally marketed predicate device.

This document does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

FDA 510(k) clearance letters primarily focus on the determination of substantial equivalence, not a detailed breakdown of clinical study results or technical performance metrics used in the study submitted to support the 510(k). The detailed performance data would typically be found within the 510(k) submission itself, which is not provided here.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device