Recruiting

i-STAT 1

Sponsor:

Abbott Point of Care

Code:

NCT07287618

Conditions

Hematologic Tests

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blood draw

Study Details

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

Study ID

NCT07287618

Start date

Sep 17, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
2. ≥ 18 years of age

Exclusion Criteria:

1\. Previous enrollment in this study

Study Design

Enrollment

425 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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.

Interventions

Blood draw

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

Primary outcome measure

  • Method Comparison for potassium (K) and ionized calcium (iCa) blood tests. [ Time Frame: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing. ]

Central Contacts and Locations

Central contacts

Miranda Gonzalez Aguirre, PhD

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

Locations

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

More Information

Sponsor

Abbott Point of Care

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Potassium (K) ionized calcium (iCa)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abbott Point of Care on 2025-12-17.