Alfa Scientific Designs, Inc. Announces First US FDA 510(k) Clearachnce for Its Driven Flow™ Tenology Product

February 22, 2018 |

2 min read

The US FDA granted the first 510(k) clearance for ALFA’s iFOB with Driven Flow™ Technology. The Instant-view-plus iFOB 510(k) clearance is indicated for professional, CLIA-waived, and over-the-counter (OTC) users.

SAN DIEGO--(BUSINESS WIRE)-- ALFA Scientific Designs, Inc. (ALFA), the US manufacturer of rapid, point-of-care (POC) medical devices, today announced that the US FDA granted the first 510(k) clearance for ALFA’s iFOB with Driven Flow™ Technology. The Instant-view-plus iFOB 510(k) clearance is indicated for professional, CLIA-waived, and over-the-counter (OTC) users. The immunoassay identifies 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.

“Improving rapid, POC diagnostics has been a major focus at ALFA throughout our 21 years, and Driven Flow™ Technology is a pinnacle achievement of our successes,” states Dr. Chai Bunyagidj, President and CEO. “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.”

Over the past few years, 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 to increase CRC screening rates. Research from both ACS and NCCRT show:

CRC is the 3rd most common cancer diagnosed in the US
CRC is the 2nd leading cause of cancer death despite its high cure rate
Death rates for people younger than 50 years of age increased 13% during 2000-2014
Early diagnosis yields a 90% cure rate, and
iFOB tests lead to early diagnosis

About Alfa Scientific:

Alfa Scientific Designs, Inc. is a leader in the development and manufacture of rapid, immunoassay, point-of-care tests. As a minority, woman-owned, small business, ALFA offers a broad range of services, including contract product development, technology transfer, OEM services, custom assembly, and packaging with private labeling. ALFA has more than 50 FDA 510(k) cleared (for professional/OTC use), CLIA-waived and CE Mark products. ALFA’s innovation in research and development has resulted in more than 27 granted patents and numerous partnerships. To learn more about ALFA’s services, development capabilities and partnership opportunities, visit the company’s website at www.alfascientific.com for more information.