Hi GonadsOther companies will not necessarily need to even get...

Hi Gonads

Other companies will not necessarily need to even get FDA 510(k) filing done to market their devices. The 510(k) was slapped on Sun due to administrative issues which would not necessetate another company doing so.

The 510(k) ruling has resulted in a lag of the business plan for the US, however overall I think it will end up being positive, as it should make buyers and distributors more interested to see they have the tick from FDA that competitors may not.

There are already competing devices, however none are as effacious in the actual detection arena - particularly with canniboids. Additionally, the spoon (patented as gsw said) is different to many of the oposition who use sponges or scrapings. My feeling is that the spitting process is simpler, more comfortable and less prone to tampering than the other methods.

To get back to your original question - yes OraLine going through FDA 510(k) could assist another company that wanted to go through it (or was compelled to), but not by much. They have to have all of their own supporting evidence that will take just as long to gather and they process will take just as long for them.