Home Usage of Conception Kit Instructions

Conceivex

Status

Unknown

Conditions

Healthy

Study type

Observational

Funder types

Industry

Identifiers

NCT00326651

Conception Kit

Details and patient eligibility

About

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.

Full 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 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

Sex

Female

Ages

16 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria