Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-26
Brief Title:
Method Comparison Study for Measuring Potassium K and Ionized Calcium iCa in Blood
Sponsor:
Abbott Point of Care
Organization:
Abbott Point of Care
Study Overview
Official Title:
Clinical Evaluation of the Potassium K and Ionized Calcium iCa Tests in Capillary Specimens Using the i-STAT CG8 Cartridge With the i-STAT 1 Analyzer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Method comparison study for Potassium K and ionized calcium iCa
Detailed Description:
The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8 Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens This objective will be assessed as part of a Method Comparison evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None