Product Classification

• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc