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The Colormate III™ is to be used as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia. Following the physician's examination within the first hours after birth, newborn babies are initially measured and periodically monitored by the Colormate III™ for incremental changes in the yellow content of the skin color as compared to the baseline Colormate III™ measurements. Babies with Colormate III™ test results indicative of hyperbilirubinemia are to be re-evaluated by the attending physician for appropriate patient management.

Colormate III™ (Colormate III or CM III) is a computer assisted noninvasive transcutaneous bilirubinometer which, through colorimetric technology, illuminates the skin of newborn babies and measures the yellow content of the skin color. The incremental changes of these color readings measured over time are compared to the newborn's baseline readings. These data are then automatically processed to provide a numerical index of estimated bilirubin count in mg/dl that has been shown to correlate with total serum bilirubin within a clinically useful range. The Colormate III, like other colorimeters, generates a set of tristimulus color coordinates for each measurement. It then performs a series of algorithms to produce final measurement results.