POV · Semen Analysis Device
Hematology · 21 CFR 864.5220 · Class 2
Overview
| Product Code | POV |
|---|---|
| Device Name | Semen Analysis Device |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
Classification Rationale
Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | Apr 9, 2026 | SESE |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | May 30, 2025 | SESE |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | May 9, 2025 | SESE |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | May 2, 2025 | SESE |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | Nov 29, 2024 | SESE |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | Aug 7, 2023 | SESE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | Oct 28, 2020 | SESE |
| K183602 | SwimCount Sperm Quality Test | Motilitycount Aps | Jun 27, 2019 | SESE |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | Nov 16, 2018 | SESE |
| K172514 | Trak Plus Male Fertility Testing System | Sandstone Diagnostics, Inc. | Nov 17, 2017 | SESE |
| K161493 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | Nov 8, 2016 | SESE |
| K153683 | Trak Male Fertility Testing System | Sandstone Diagnostics, Inc. | May 16, 2016 | SESE |
| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | May 4, 2010 | SESE |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | Jan 24, 2008 | SESE |
| K071737 | GENERAL SEMEN ANALYSIS KIT | Dyn-Bioshaf (2006) , Ltd. | Oct 25, 2007 | SESE |
| K063864 | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS | Medical Electronic Systems , Ltd. | Mar 26, 2007 | SESE |
| K041039 | FERTELL MALE FERTILITY TEST | Genosis , Ltd. | Jul 20, 2004 | SESE |
| K032874 | HBA SPERM-HYALURONAN BINDING ASSAY | Biocoat, Inc. | Nov 24, 2003 | SESE |
| K024337 | GENERAL SEMEN ANALYSIS (GSA) KIT | Bioshaf , Ltd. | Jul 3, 2003 | SESE |
| K021746 | SQA V, SPERM QUALITY ANALYZER | Medical Electronic Systems, LLC | Sep 20, 2002 | SESE |
Top Applicants
- Medical Electronic Systems , Ltd. — 5 clearances
- Bonraybio Co., Ltd. — 4 clearances
- Embryotech Laboratories, Inc. — 2 clearances
- Hamilton Thorne Research — 2 clearances
- Medical Electronic Systems, LLC — 2 clearances
