Semen Analysis Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K915229 ↗

FDA Product Code

POV

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-Mbb, 10-Mbb-B, 10-Mpb, 10-Mpb-B

  Class II

  FDA 510(k) K012811 Active Cleared 11 Feb 2002

• Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E, 1452EL, 1452l

  Class II

  FDA 510(k) K990941 Active Cleared 14 Jul 1999

• Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-Pp-9, 16-Pp-5.75

  Class II

  FDA 510(k) K000915 Active Cleared 12 May 2000

• Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M

  Class II

  FDA 510(k) K990847 Active Cleared 14 Jul 1999

• What clinical parameters does the Semen Analysis Kit measure, and how does it help in fertility assessment?

  The Semen Analysis Kit evaluates semen samples for key fertility-related metrics, including sperm concentration, motility, and morphology. These measurements provide quantitative and qualitative insights into sperm health, which are critical for diagnosing male infertility and guiding reproductive health decisions in clinical or laboratory settings.

• Is the Semen Analysis Kit designed for single-use or repeated use, and how should it be stored to maintain sterility?

  The kit is explicitly designed as a sterile, single-use device to ensure accuracy and prevent contamination. To maintain sterility, it must be stored according to the manufacturer’s instructions—typically in a clean, dry environment away from direct sunlight or extreme temperatures—until immediate use.

• What regulatory pathway does the Semen Analysis Kit follow, and which advisory committee oversees its classification?

  The kit follows the FDA 510(k) clearance pathway and is classified under Class II (Regulation 864.5220) for hematology-related applications. Its substantial equivalence determination was reviewed by the Hematology (HE) Advisory Committee in 1994, ensuring compliance with U.S. regulatory standards for diagnostic devices.

• Can this kit be used outside of a clinical or laboratory setting, or is it restricted to professional use?

  The Semen Analysis Kit is intended exclusively for use in clinical or laboratory settings, where trained professionals can perform accurate fertility assessments. Its design and sterility requirements make it unsuitable for home or non-professional use.