Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03134326

Run by

Masimo Corporation

People needed

21

Starts

2009-06-18

Expected to finish

2009-07-02

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Greater than 18 years old
• Healthy

You may not qualify if…

• Do not understand the study and the risks involved
• Deemed ineligible by study test personnel

Where it is running

• Masimo Clinical Lab — Irvine, California, United States

Full record on ClinicalTrials.gov

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