Study on how the VACUETTE® K3E K3EDTA Tube performs

Performance evaluation of VACUETTE® K3E K3EDTA Tube - Performance evaluation of VACUETTE® K3E K3EDTA Tube

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON61424

Enrollment

100

Registered

2026-05-15

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Haematological and immunohaematological performance assessment Evaluation of blood cell and blood type testing

Interventions

VACUETTE® K3E K3EDTA Tube (Prod.no.: 454036, 4mL)&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subject’s age = 18 years (apparently healthy subjects and subjects with health conditions/diseases)Subject’s body weight > 50 kgSubject has signed the Informed Consent FormSubject is able to understand the background and purpose of the study   

Exclusion criteria

Exclusion criteria: Subjects for whom venous blood sampling is not feasible, e.g., due to poor venous conditions (requiring more than two attempts to puncture the vein)Subjects that shall not be included based on the Principal and/or Sub Investigator's discretion Breastfeeding and pregnant women (self-reported)   

Design outcomes

Primary

Measure	Time frame
VACUETTE® K3E K3EDTA Tubes for venous blood collection have been available on the market for several years. This clinical study represents a performance evaluation intended to demonstrate the analytical performance of the candidate devices VACUETTE® K3E K3EDTA Tubes compared to the predicate devices Becton Dickinson (BD) Vacutainer® K3EDTA Tubes by analysis of the Complete Blood Count (CBC) & differential, ABO blood grouping (forward and reverse typing) and Rhesus D (RhD) typing.	—

Measure

Time frame

VACUETTE® K3E K3EDTA Tubes for venous blood collection have been available on the market for several years. This clinical study represents a performance evaluation intended to demonstrate the analytical performance of the candidate devices VACUETTE® K3E K3EDTA Tubes compared to the predicate devices Becton Dickinson (BD) Vacutainer® K3EDTA Tubes by analysis of the Complete Blood Count (CBC) & differential, ABO blood grouping (forward and reverse typing) and Rhesus D (RhD) typing.  

—

Countries

Netherlands

Contacts

Public ContactN Vacha

Greiner Bio-One GmbH

nina.vacha@gbo.com+43 7583 6791-0

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026