Chromatics Color Sciences International. Inc; CCSI Message Board

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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI

CCSI 24.53

-1.9%

3:59 PM EST

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To: JanyBlueEyes who wrote (3400)	6/23/1998 7:36:00 PM
From: Robin	Read Replies (2) of 5736

To all: Yes, read it again and carefully this time! From the press release! >> The Company's clearance letter from the Food and Drug Administration allows the Intended Use of the Colormate device ''to provide a numerical index of predicted serum bilirubin count in mg/dl that has been shown to correlate with Total serum Bilirubin concentration within a clinically useful range,'' << If I read this correctly, the company itself is admitting that the device is useful to measure total bilirubin only and approved for such use only. No claim of the ability to measure direct vs. indirect bilirubin concentrations can be implied from this statement. So what good is an additional measurement with the device once a diagnosis has been made! This cuts down on the potential usage of the product (used up to the point diagnosis is made, but essentially useless during management of the condition). Personally, I would want my doctor to switch to the heel prick for the best interests of my child (trade a little pain for better care) once a diagnosis is made. Does anyone know if it is possible to get a false negative reading when reading total bilirubin only? If so, then there is no potential usage for this product, IMO, once product and medical liability are taken into account. Rockin' Robin

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