Akers Biosciences, Inc. – FDA Warning Letter, May 9, 2011

The FDA inspected Akers Biosciences, Inc. from April 26 to May 9, 2011, and found violations regarding their in vitro diagnostic testing kits, specifically the Battlefield Blood Transfusion Card. This device is classified as a Class III device under section 513(f) of the Federal Food, Drug and Cosmetic Act (the Act).

The primary violation is that the Battlefield Blood Transfusion Cards are adulterated under section 501(f)(1)(B) of the Act because they have not received premarket approval under section 515 or an investigational device exemption (IDE) under section 520(g). The company also violated the law by offering these devices for sale without obtaining marketing approval or clearance. Additionally, the devices are misbranded under section 502(o) of the Act because the company failed to notify the FDA of their intent to introduce the device into commercial distribution, as required by section 510(k).

Akers Biosciences, Inc. submitted two written responses on May 23 and May 31, 2011, detailing corrective actions, but these responses did not address the lack of premarket approval or clearance for the Battlefield Blood Transfusion Card.

The FDA requires prompt action to correct these violations. Failure to do so may result in regulatory actions such as seizure, injunction, and/or civil money penalties. Federal agencies are also informed of Warning