Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326651
Status:
UNKNOWN
Last Update Posted:
2007-02-01
First Post:
2006-05-15
Brief Title:
Home Usage of Conception Kit Instructions
Sponsor:
Conceivex
Organization:
Conceivex
Study Overview
Official Title:
Home Usage of Conception Kit Instructions
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website wwwconceptionkitcom
Detailed Description:
Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use
All Components have 510K clearance This study is a validation of the instructions for use IFU only
OPK Class I Device 21CFR 8621485 Conception Cap K993953 Pregnancy Test Kit K974059 Semen Collection Device K902936 21CFR 8845300
Conception Kit has CE Marked by GMED Certificate 2037
Conceivex is an ISO 13485 2003 company
All Components have 510K clearance This study is a validation of the instructions for use IFU only
OPK Class I Device 21CFR 8621485 Conception Cap K993953 Pregnancy Test Kit K974059 Semen Collection Device K902936 21CFR 8845300
Conception Kit has CE Marked by GMED Certificate 2037
Conceivex is an ISO 13485 2003 company
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None