Headache,
I will give you my opinion, and then we will see if Bocxman agrees or not.
Abbott has a semi-exclusive license to implement the RECAF blood tests into Abbott's Architect system. That is the extent of their license of RECAF technology. The new product, test, or implementing that Abbott decides to use may or may not need FDA approval. If it is classified as a Class I medical device it does not need premarket approval from FDA. It also does not require a 510k premarket notification. A Class II device requires a 510k premarket notification, and a Class III device requires a PMA (premarketing approval) along with possibly years of clinical trials for testing. Bocxman's "clinical indication" term just referred to what may or may not be required by the FDA. If Abbott is only developing the RECAF blood test technology into a Class I medical device, the time to market is short, and that is in our best interest as BOCX investors. kag
