From Asensio:
"In fact, CCSI's FDA approval is based on the fact that the Colormate III is "substantially
equivalent" to other existing colorimeters, including one that has been on the market for well
over forty years."
The FDA approval was based on nothing of the kind. The FDA compared Colormate III with two (note: only two) other devices. They said:
" The Colormate III is "substantially equivalent" (as defined in 21 U.S.C. S 360c(i)) in principle, performance,
and safety and effectiveness to at least two legally marketed predicate devices. The first predicate device, the
Unistat Bilirubinometer manufactured by Leica, Inc.(K922770), is a bilirubinometer which operates by
measuring the absorption of visible light through a sample of unreacted serum. The absorption at several
wavelengths determines the level of bilirubin present in the sample. The second device, the Ingram Icterometer,
commercially distributed preenactment (marketed since 1950's) by Cascade Health Care Products, Salem,
Oregon, is a noninvasive aid used as a color reference by the physician during his/her visual assessment of the
newborn's skin for jaundice or yellowing. The yellow color of the subcutaneous tissue is matched to a
corresponding "yellow hue" stripe for a reference score."
The first device is a bilirubinometer that REQUIRES A BLOOD SAMPLE. The second "device" is the one Asensio excitedly reports "has been on the market for well over forty years". (It was on the market "preenactment", i.e., before the FDA issued verdicts on such mechanical devices). It's noninvasive all right. It doesn't do anything as far as I can see. It DEPENDS ON VISUAL ASSESSMENT BY THE PHYSICIAN. The FDA: "The painted stripes of precisely graded yellow hues in the Ingram Icterometer provide the physician with a visual aid to gauge the depth of jaundice in the newborns and estimate the serum bilirubin levels." It sounds like the second device is nothing more than a bunch of closely graded painted stripes, with some implied bilirubin levels along side each, which the tired eyes of the physician tries to compare to the newborn's skin, LOL.
The FDA's term "substantially equivalent" does not mean "roughly the same" in the usual sense. It has a technical meaning. Many products given FDA approval as "substantially equivalent" to existing products are clearly superior to the referenced products. It is obvious from the FDA report that Colormate III differs substantially from both of the referenced products. The FDA said nothing about other devices.
Wade |
