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| Name | Class |
|---|---|
| Bionostics | UNKNOWN |
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To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.
This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in analyte values obtained from three different blood gas syringes for each analyzer tested | For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer. | Blood analysis within 30 minutes of draw |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Cifaldi, BS, RRT | Smiths Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bionostics | Devens | Massachusetts | 01434 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2017 | |
| Reset | Jul 31, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2017 | Jul 31, 2017 |
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