Pharmacia Diagnostics innovated the technology looking at IgE and allergy in the laboratory, and we continue to perform research and development in this specialized area, always working to improve and enhance the science to create ongoing better diagnostic tools. Well, the technology is already on the market. And the majority of laboratories in the US do offer this technology. Yes, these products are FDA cleared. We have the largest number of allergens cleared in the market.
Every allergen needs to be evaluated.
510K is the clearance that the FDA has, as opposed to what's known as a PMA, which is a pre-market approval. Pre-market approvals are usually for drugs, pharmaceuticals, and normally the 510K process is utilized for devices in diagnostics. You cannot market and promote technologies that are not FDA cleared. Usually, an FDA clearance will mean that products are safe and effective. There are some allergy in vitro assays that laboratories perform that are not FDA cleared, which is another reason health care professionals and patients should ask specifically for the ImmunoCap technology.