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Study on Evaluating the performance of the medical device ADVIA 2120i Hematology analyser

Performance Qualification of ADVIA 2120i Hematology analyser - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064212
Enrollment
30
Registered
2024-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

None listed

Interventions

Intervention1: ADVIA 2120i Hematology analyser: ADVIA 2120i Hematology analyser Intervention2: NIL: NIL Intervention3: NIL: NIL Control Intervention1: Automated Hematology Analyzer (Sysmex XN series):

Sponsors

HCL Technologies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Partcipants to be in good health, as determined by health evaluation. Participants agree to provide informed consent.

Exclusion criteria

Exclusion criteria: Participants with any significant medical condition. Participants with abnormal laboratory results. Participants with concomitant medication. Partcipants with above 45 years of age. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
to assess the performance and calibrate the ADVIA 2120i Analyzer system The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC and haemoglobinTimepoint: to assess the performance and calibrate the ADVIA 2120i Analyzer system at day 30. The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC and haemoglobin—

Secondary

MeasureTime frame
The successful performance qualification of the ADVIA 2120i Analyzer enables to perform the design verification with respect to hardware & software engineering changes. The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC & haemoglobin after 30 daysTimepoint: The successful performance qualification of the ADVIA 2120i Analyzer enables to perform the design verification with respect to hardware & software engineering changes at end of the study The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC & haemoglobin after 30 days—

Countries

India

Contacts

Public ContactDr.B.Mothish waran

SRM Institute of Science and technoogy, Interdisciplinary Institute of Indian system of Medicine

ayursatish@gmail.com9884845997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026