Performance Data - Dräger JM-103 Instructions Manual

Performance Data

The data in the following sections is provided to demonstrate results of
the JM-103 clinical studies, in comparison to total serum bilirubin. The
JM-103 reports values over a range of 0-20 mg/dL estimated bilirubin.
Although the doctor's office study showed correlation of JM-103 to the
TSB laboratory values, the relationship (bias) of the JM-103 to the TSB
values was somewhat different than previously reported for hospital
sites (as previously shown in Appendix A). This may be related to the
ages of the infants in the doctor's office study and the difference in
individual development. Therefore, please be aware that results at
doctors offices may differ from results at hospitals and may have more
variability.
The reported data shows that 27% of the JM-103 measurements were
higher than the Laboratory TSB and 71% were lower (2% were matched
sets). Of the readings falling below the TSB value, 87% were within 3
Mg/dL of the TSB value. Those readings that reported above the TSB
value 94% were within 3 Mg/dL of the reported TSB value. The largest
error was a single 5.2 Mg/dL reading. The serum bilirubin
measurements were taken using direct spectrophotometry and the
Beckman-Coulter Synchron LX-20.
See regression analysis and infant age graphs below for data at the
individual sites. A regression analysis is also provided on the total of
201 infants.
Jaundice Meter Instructions for Use (MU01380)
DRAFT 20 June 2005
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