The Nanotainer

“The other issue is that blood pricked from the finger is actually less pure from a point of view of getting accurate results than venous blood, because it's polluted with tissue from cells, and you know when, when you prick the finger and you milk the blood from the finger...”
- John Carreyrou

This is an absolute false statement. Blood is blood. Doesn't matter if it's from the finger or the vein or if I slice myself open and drip it into a tube, blood is blood!

THE FDA Overstepped their Authority and caused Theranos to ONLY Draw blood from Regular FDA Approved tubes. When this happened, it appeared to everyone that Theranos is doing what every other lab is doing, drawing blood tubes from the vein and running them on commercial analyzers. Investors didn’t invest in an ordinary laboratory….. Where’s the nanotainer? Here’s what happened;

Theranos had an LDT-a laboratory-developed test. The nanotainer was part of that LDT. Under CLIA & CAP regulation, that's perfectly fine. As long as you're not selling the nanotainer to outside commercial labs.

You don't need an FDA 510K and the FDA has nothing to do with it. So, for the FDA to step in and shut them down stating they needed an approval for a Class II medical device and that Theranos was marketing and selling them across state lines. This is illegal from the FDA. No wonder why RFJ Jr. head of HHS got rid of I think 10,000 FDA employees. This is absurd. Here’s the LDT regulation and a Recent Federal Judge Ruling that FDA overstepped with LDT’s.