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# Test for Detecting Blood in Stool Cleared
- URL: https://www.fdaweb.com/test-for-detecting-blood-in-stool-cleared/
- Published: 2017-11-13T12:00:00.000Z
- Updated: 2026-09-14T23:01:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140116

FDA has cleared a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test intended to detect blood in stool. The device detects human hemoglobin in fecal samples to aid in identifying lower gastrointestinal bleeding. It requires sample collection from one bowel movement by the patient, versus the two samples required by the companies’ previous InSure FIT, its predicate test. “Unlike other FITs, InSure ONE only requires a sample of water from the toilet bowl,” the companies say The toilet bowl water is collected after brushing the surface of the stool to release any blood into the surrounding water.