Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-01 @ 4:54 PM
Study NCT ID:
NCT03243266
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2017-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DxH520 Pediatric Reference Interval Verification
Sponsor:
Beckman Coulter, Inc.
Organization:
Study Overview
Official Title:
DxH520 Pediatric Reference Interval Verification
Status:
COMPLETED
Status Verified Date:
2018-07
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:
Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
Detailed Description:
Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:
1. Neonate: 0 to 30 days
2. Infant: \> 30 days to 2 years
3. Child: 3 years to 12 years
4. Adolescent: 13 years to 21 years
1. Neonate: 0 to 30 days
2. Infant: \> 30 days to 2 years
3. Child: 3 years to 12 years
4. Adolescent: 13 years to 21 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: