Precision Study Measuring Potassium (K) in Capillary Specimens

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06291493

Enrollment

161

Registered

2024-03-04

Start date

2024-05-07

Completion date

2024-09-13

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precision of Potassium (K) Test in Capillary Whole Blood

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.

Interventions

DIAGNOSTIC_TESTFingerstick blood draw

Capillary blood specimen collected from two separate fingerstick blood draws.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Capillary precision analysis will be performed for Potassium K.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Signed and dated consent form (if required by the IRB) * ≥ 18 years of age

Exclusion criteria

• Prior enrollment in the study

Design outcomes

Primary

Measure	Time frame	Description
Precision for Potassium (K) Test	Up to 5 minutes	Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026