Stopped: Patient recruitment too slowly
The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.
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Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison
Timeframe: 20 days
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison
Timeframe: 20 days
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison
Timeframe: 20 days