StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood

Anemia, Bleeding, Erythrocytosis, Sepsis

Lactate, Hemoglobin, Hematocrict

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.

The study will be conducted at three (3) different healthcare settings (hereafter referred to as testing sites) in POC sites/departments, by at least nine (9) CLIAW operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. Examples of hospital departments include (but are not limited to) Emergency Department (ED), Intensive Care Unit (ICU), Pediatric Intensive Care Unit (PICU), Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Cardiac Intensive Care Unit (CICU), Operating Room (OR), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized. Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females. Each Study Subject will provide: 1. Two (2) capillary whole blood fingerstick specimens 1. One Lactate capillary test using the Fingerstick Blood Contamination Barrier 2. One Hb/Hct capillary test following traditional fingerstick protocol 2. One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe: 1. One lactate venous test 2. One Hb/Hct venous test

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United States