DRAFT 20 June 2005
Jaundice Meter Instructions for Use (MU01380) Page B - 1
Appendix B
Doctors’ Office Data
Study Design
Studies were performed at two doctors’ office sites comparing JM-103
Total Calculated Bilirubin (TcB) to laboratory measured total serum
bilirubin (TSB).
Selection Criteria
The ages of the infants in the study ranged from approximately 24 hours
to 7-10 days, with a mean of 3 days (at site 1) and 5 days (at site 2). The
test was performed on infants who were determined by their physician
to require a serum bilirubin test.
Demographics of Patient Population
All patients meeting the above criteria were included in the study. The
majority of babies were Caucasian or no skin tone noted (n=167) with a
small number of reported ethnicity defined infants (n=34). The
demographics of the patient population included Caucasian, African-
American, and other.
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