Hematologic TestsK iCaNCT07287618
Evaluation of Potassium (K) and Ionized Calcium (iCa) Tests Using Capillary Specimens
An observational study of Hematologic Tests, run by Abbott Point of Care at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Tests
- What is being tested?
- Blood draw
- How many people
- 425 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Sep 2025to 26 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intended use population.
Who may be able to join
- Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
- ≥ 18 years of age
Who cannot join
- 1. Previous enrollment in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Penn State Health Milton S. Hershey Medical Center (Hershey)
Hershey, Pennsylvania, 17033
Medical College of Wisconsin
Milwauke, Wisconsin, 53226
About this study
Official title: Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
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.
Read the 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
- Being tested
- Blood draw
- Keywords
- Potassium (K) ionized calcium (iCa)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Capillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start17 Sep 2025
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Point of Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Gupta, MS, MBA, Study director, Abbott Point of Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287618
- Sponsor's protocol ID
- CS-2025-0001
- Acronym
- K iCa
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
- ClinicalTrials.gov ID
- NCT07287618
- Acronym / sponsor ID
- K iCa / CS-2025-0001
- Conditions
- Hematologic Tests
- Keywords
- Potassium (K) ionized calcium (iCa)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Abbott Point of CareIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Method comparison for K and iCa tests using capillary whole blood specimens. | – | Diagnostic Test: Blood drawPerformance 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intended use population.
Key inclusion criteria (2 listed)
- Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
- ≥ 18 years of age
Key exclusion criteria (1 listed)
- 1. Previous enrollment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawCapillary whole blood specimens collected from fingerstick(s) from each enrolled subject using blood collection capillary tubes. | Diagnostic test | Method comparison for K and iCa tests using capillary whole blood specimens. |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Gupta, MS, MBA study director
Abbott Point of Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Tests, run by Abbott Point of Care at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.