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.
| Device Type ID | 2449 |
| Device Name | Semen Analysis Device |
| 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 Description | Automated Differential Cell Counter. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2449 |
| Device | Semen Analysis Device |
| Product Code | POV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Differential Cell Counter. |
| CFR Regulation Number | 864.5220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BONRAYBIO CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SANDSTONE DX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |