Akers Biosciences Inc. withdrew its initial 510(k) application to the U.S. Food and Drug Administration for the company's chlamydia rapid blood test device.
Following a recommendation by the U.S. drug regulator, Akers Biosciences is withdrawing the PIFA chlamydia rapid assay to re-evaluate its options in developing the product.
The PIFA chlamydia rapid assay is a diagnostic test device for chlamydia, a common sexually transmitted infection.
"The setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the company," said John Gormally, CEO of the Thorofare, N.J.-based healthcare equipment company.
