BioCurex, Inc.(fka BOCX)

[Gold Seeker]

"From the WHISPERING OAKS INTERNATIONAL INC - BOCX Annual Report

Biocurex anticipates that its serum assay, if successfully developed, will be classified as a Class II medical device."

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The above is from the annual report. Class two devices may be approved via a 510(k) if a predicate exists or via a PMA if a predicate does not exist.

As of a couple years ago, there has been a tightening of controls at the FDA after the Vioxx situation. No one at the FDA is going to jeopardize their career with a loose interpretation of a predicate test for RECAF. Nothing out there is similar to RECAF.

Below is a list of PMA approvals for 2004. Note the tests by Abbott and the fact that most took 180 days for approval.

http://www.fda.gov/cdrh/pma/pmafeb04.html