Search Results
Found 1 results
510(k) Data Aggregation
K Number
K161493Device Name
YO Home Sperm Test
Manufacturer
MEDICAL ELECTRONIC SYSTEMS, LTD
Date Cleared
2016-11-08
(160 days)
Product Code
POV
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC SYSTEMS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The YO™ Home Sperm Test is a smartphone based home test which provides a qualitative assessment of motile sperm concentration (MSC) in human semen. MSC is one aspect of a male semen examination. The YO™ Home Sperm Test does not provide a comprehensive evaluation of a male's fertility status and is intended for over-the-counter, in vitro use only.
Device Description
YO™ is an over-the-counter device that provides a qualitative assessment of motile sperm concentration (MSC) in human semen. Results are reported as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE," requiring no user interpretation. The YO™ software application is downloaded onto the users' own smartphone and on-screen menus and instructions are shown on the phone's display so that the user is taken through the process step by step. The YO™ kit (purchased on the website) provides all the supplies necessary to evaluate two semen samples: two semen collection cups, two vials of liquefying powder (chymotrypsin), two pipettes for sample aspiration, two fixed coverslip slides for sample testing, one QC slide, and one YOT™ Clip that attaches to the smartphone and houses the fixed coverslip slide.
Ask a Question
Page 1 of 1