Theranos receives FDA 510(k) clearance and review and validation of revolutionary finger stick technology, test, and associated test system

by Theranos

PALO ALTO, Cal. (July 2, 2015) – Theranos, Inc. (Theranos) today announced that it has received the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of its test system and test for herpes simplex 1 virus IgG. The FDA’s decision provides independent validation of Theranos’ patented finger stick and venous blood testing technology and the ground breaking Theranos System upon which the HSV-1 IgG test is run, as well as the approach that the company has supported for FDA review of Laboratory Developed Tests (LDTs).

The FDA decision involved extensive review of the Theranos System, a highly-automated platform designed to mitigate the human error traditionally associated with the manual processing of samples. The FDA clearance includes the use of Theranos’ Nanotainer™ Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger. The Theranos System, including Theranos’ device, analytical software, and Nanotainer™ Tubes, has been fully validated and cleared for use with this test method.

FDA’s review process for 510(k) notifications is widely recognized as one of the most rigorous regulatory hurdles in the world for evaluation of the performance, accuracy, and intended use of diagnostic tests. Today’s announcement demonstrates that Theranos has met that standard and is an important step in Theranos’ mission to make health information accessible to people at the time it matters, enabling early detection and prevention of disease, and empowering individuals everywhere with information to live healthier lives – a mission that depends on patients knowing they are getting results they can trust.

“We are proud to have received our first FDA clearance,” said Elizabeth Holmes, the founder and CEO of Theranos. “In order to realize our vision of early detection, lab tests must meet the highest quality standards — standards that are comprehensively set by FDA. FDA review is a uniquely rigorous process we undertook voluntarily because we remain deeply committed to ensuring that our systems and all of our laboratory developed tests are of the highest quality, and that patients and their physicians have access to the most accurate information about their health. We look forward to continuing our strong working relationship with the Agency on further applications.”

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