Device |
semen analysis device |
Regulation Description |
Automated differential cell counter. |
Definition |
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH. |
Physical State |
Semen analysis devices may be found in a range of shapes and sizes with various distinguishing features. |
Technical Method |
The device may use one or more forms of technology including optical, mechanical, digital imaging, computer algorithms, chromatographic immunoassay and may be manual, automated, or semi-automated. |
Target Area |
Human semen |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | POV |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
864.5220
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|
|
|