Alfa Scientific Designs assert FDA 510(k) clearance for Driven Flow Technology

Alfa Scientific Designs, the US manufacturer of rapid, point-of care medical devices asserted that the FDA has extended the 510(k) clearance for  ALFA’s iFOB with Driven Flow Technology. The instant-view-plus iFOB 510(k) clearance is suggested for CLIA-waived, and over-the-counter (OTC) users.

The immunoassay ascertains human blood in feces, a possible symptom of pre-cancerous polyps and Colorectal Cancer (CRC). ALFA’s iFOB test requires only one drop of sample solution with the result appearing as soon as 1 minute, demonstrating a 5-fold increase in speed in comparison to standard lateral flow assays.

Dr. Chai Bunyagidj, President and CEO said “Receiving this 510(k) clearance accomplishes a significant milestone for us and, we believe, all rapid, POC diagnostic test end-users. ALFA’s iFOB with Driven Flow™ Technology is a noteworthy improvement to our industry’s lateral flow platform because it stands poised to improve patient outcomes.”

iFOB tests, also known as Fecal Immunochemical Tests (FIT), have gained prominence in the general public. Because positive test results may be an indication of CRC, education about the importance of CRC screening is vital. Educational efforts by the American Cancer Society (ACS) include CRC program funding, and the National Colorectal Cancer Roundtable (NCCRT) launched the 80% by 2018 campaign.