At a glance
ClinicalIndex Comparison Record- ✓Adult aged >18 years
- ✓Healthy status
- ✕Inability to understand study and associated risks
- ✕Deemed ineligible by study test personnel
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
In Brief
A clinical study evaluating R1-25 and R2-25 Pulse Oximeter Sensor for Healthy. Completed, enrolled 21 participants across 1 site.
Detailed Summary
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.