Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT06291493
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Study Measuring Potassium (K) in Capillary Specimens
Sponsor:
Abbott Point of Care
Organization:
Study Overview
Official Title:
Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
Status:
COMPLETED
Status Verified Date:
2025-03
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:
Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.
Detailed Description:
The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.
Study Oversight
Has Oversight DMC:
False
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?: