Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778553
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2021-02-26
Brief Title:
Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study
Sponsor:
Essenlix Corporation
Organization:
Essenlix Corporation
Study Overview
Official Title:
Clinical Evaluation of the iMOST Analyzer - Matrix Study Comparing Capillary and Venous Whole Blood
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a method comparison study for an in vitro diagnostic device The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary eg fingerstick blood The study compared the CBC results from the test device the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C analyzer The CBC parameters were hemoglobin White Blood Cells WBC and the WBC Differential for Granulocytes Neutrophils Lymphocytes and Monocytes The study subjects were patient donors age 18 and older attending the hospital clinic from whom Informed Consent had been received
Detailed Description:
These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens Furthermore there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system As has been published in the peer reviewed literature different fingerstick sample collection methods yield slightly different CBC results specifically the WBC and the WBC Differential The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results All three methods of blood collection are thus described in the Instructions for Use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None