Search Results

The LifeGuard™ is a guaiac-based test for the qualitative detection of occult blood in stool, which may indicate gastrointestinal disease. Patients can purchase the test without a prescription from stores or Internet distributors in order to perform testing at home. Users obtain their own stool samples by wiping onto the test device, then develop the tests, read the test results, and send a report of the results to their physician. LifeGuard™ is useful as an aid in the diagnosis of a number of gastrointestinal disorders and is used for colorectal cancer screening programs. The American Cancer Society recommends that at least three consecutive bowel movements be tested due to the irregularity of bleeding from some intestinal lesions. Therefore, the LifeGuard™ home test kit includes three test wipes for testing three closely spaced bowel movements.

The LifeGuard™ is a guaiac-based test for the qualitative detection of occult blood in stool.

This document is a 510(k) premarket notification acceptance letter for the LifeGuard™ occult blood test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or any studies conducted.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval process and includes no technical or clinical study data.

Ask a specific question about this device