Home Usage of Conception Kit Instructions
Recruitment status was Active, not recruiting
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: www.conceptionkit.com.
|Study Design:||Observational Model: Natural History
Time Perspective: Longitudinal
|Official Title:||Home Usage of Conception Kit Instructions|
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2007|
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 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300),
Conception Kit has CE Marked by GMED. (Certificate 2037)
Conceivex is an ISO 13485: 2003 company
|United States, Michigan|
|Dr. Charles Barker|
|Belding, Michigan, United States, 48809|
|Dr. Dorsey Ligon|
|Grand Rapids, Michigan, United States, 49503|
|Study Director:||Michael G La Vean||Study Coordinator|