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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: JanyBlueEyes who wrote (2824)	6/11/1998 5:35:00 PM
From: Quad Sevens	Read Replies (2) \| Respond to of 5736

<< "The basic concept behind obtaining 510(k) clearance is that the device being reviewed is very much like others already being sold in the United States....". This statement says it all. >> You think so? I thought Darby's point in today's release was just the opposite: the FDA's "substantial equivalence" need not mean what it sounds like. The two devices the FDA found the CIII "substantially equivalent" to were not very much like it--in any ordinary sense. One of them (laughable really, from the 50s) requires the physician to make a visual assessment based on painted, coded (for bilirubin level) color-stripes of yellow hue supplied by the manufacturer. The FDA found CIII far superior to visual assessment, and by implication, this device. (Asensio explicitly stated the "colorimeter" from the 50s was as good as CIII. That's because he's a liar.) The other device was a bilirubinometer that requires blood to be drawn. As we know, a crucial difference is that the CIII is non-invasive. So ... "substantial equivalence" is an FDA term that has a specialized meaning frequently at odds with "very much like". Asensio knows this, and a court will know he knows this. He's committed fraud here. In fact, his statements on the CIII are so deranged it makes me think he has something else up his sleeve. Wade