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

NCT07287618 | Recruiting FDA Device

• 1 other identifier: CS-2025-0001
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hematologic Tests

Keywords

Potassium (K) ionized calcium (iCa)

Outcome Measures

Primary Outcomes (1)

• Method Comparison for potassium (K) and ionized calcium (iCa) blood tests.

  Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with prospectively collected capillary specimens. Subjects with one valid capillary result on the i-STAT CG8+ cartridge and one valid result on the comparator blood analysis system will be evaluated.

  Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.

Study Arms (1)

Method comparison for K and iCa tests using capillary whole blood specimens.

OTHER

Performance comparison: Using results from capillary whole blood specimens collected from fingerstick(s) from each subject enrolled in the study, the performance between i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on i-STAT 1 analyzer and a comparator blood analysis system will be compared.

Diagnostic Test: Blood draw

Interventions

Blood draw DIAGNOSTIC_TEST

Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.

Method comparison for K and iCa tests using capillary whole blood specimens.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
• ≥ 18 years of age

You may not qualify if:

• \. Previous enrollment in this study

Sponsors & Collaborators

• Abbott Point of Care: lead

Study Sites (3)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center (Hershey)

Hershey, Pennsylvania, 17033, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Manish Gupta, MS, MBA

  Abbott Point of Care

  STUDY DIRECTOR

Central Study Contacts

Miranda Gonzalez Aguirre, PhD

CONTACT

613-604-8539; miranda.gonzalezaguirre@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Method Comparison Study

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)