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Completed

NCT Number: NCT06291493

Precision Study Measuring Potassium (K) in Capillary Specimens

Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Point of Care (APOC), Ottawa, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior enrollment in the study

Treatment and study plan

Fingerstick blood draw

Diagnostic Test

Capillary blood specimen collected from two separate fingerstick blood draws.

Other names: Blood draw

Primary outcomes

  1. Precision for Potassium (K) Test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Abbott Point of Care

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.