CORTLANDT MANOR, N.Y.—Polymedco, Inc., received U.S. Food and Drug Administration (FDA) 510(k) clearance of the OC-Sensor Diana, a high throughput automated system for the immunoassay fecal occult blood test (FIT) used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and colitis.
The new OC-Sensor Diana system measures 280 FIT samples per hour and ensures that quality data is consistently collected. In addition, its compact design, only 24.8" by 22" by 22" and 133 lbs., is ideal for workstation set-up. The FIT system screening method provides increased sensitivity and specificity over traditional screening methods. Indicated for use in routine physical examinations, the test measures the presence of human hemoglobin in a patient's stool. The results assist physicians in recommending patients to colonoscopy, leading to the detection and treatment of colorectal cancer at an earlier stage.
Personal use iFOBT packs allow the patient to easily collect a sample and return it to the lab for quick and accurate results. The iFOBT requires no dietary or medicinal restrictions and only a single sample collection, making it easier and more comfortable for use versus other methods.