NCT07287618

Evaluation of Potassium (K) and Ionized Calcium (iCa) Tests Using Capillary Specimens

Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 425 (estimated)
• Sponsor: Abbott Point of Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the performance of blood tests using the i-STAT 1 System against a comparator blood analysis system.

Detailed description

To compare the performance of the i-STAT potassium (K) and ionized calcium (iCa) tests using the i-STAT CG8+ cartridge on the i-STAT 1 analyzer to the performance of K and iCa tests on a comparator blood analysis system using results from two separate capillary specimens from each subject enrolled in the study.

Conditions

• Hematologic Tests

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draw	Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.

Timeline

• Start date: 2025-09-17
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study