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SpermCheck Vasectomy

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073039

by Princeton Biomeditech Corp.

Identifiers

510(k) Number
K073039 FDA 510(k)
FDA Product Code
POV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5220 FDA 510(k)
Regulation Number
864.5220 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SpermCheck Vasectomy is a semen analysis device designed to detect the presence of sperm in semen samples. Classified under the nomenclature for hematology devices, it provides a qualitative assessment to confirm sperm-free status post-vasectomy, aiding in fertility verification and surgical outcome confirmation. The device operates as a point-of-care tool for at-home or clinical use, offering rapid results without requiring specialized laboratory infrastructure.

This device is supplied as a single-use, non-sterile kit intended for home or clinical testing. It falls under FDA product code POV and has received FDA 510(k) clearance through the Traditional pathway, classified as a Class II device. Storage and handling follow standard guidelines for diagnostic test kits, with no MRI safety considerations. Authorized for use in the United States, it adheres to regulatory requirements for semen analysis devices as outlined in 21 CFR 864.5220.

Frequently asked questions

What is the SpermCheck Vasectomy device used for?

The SpermCheck Vasectomy is designed to detect the presence or absence of sperm in semen samples. It provides a qualitative assessment to confirm sperm-free status after a vasectomy procedure, helping verify surgical success and fertility outcomes. This is particularly useful for patients and clinicians needing quick, point-of-care results without relying on laboratory infrastructure.

How is the SpermCheck Vasectomy device supplied and intended for use?

The device is supplied as a single-use, non-sterile kit, making it suitable for both at-home and clinical testing. It is engineered as a point-of-care tool, allowing for immediate results without the need for specialized laboratory equipment. This design ensures accessibility and convenience for users seeking rapid confirmation of sperm-free status.

Is the SpermCheck Vasectomy device sterile?

No, the SpermCheck Vasectomy device is explicitly labeled as non-sterile. Since it is intended for single-use and designed for qualitative semen analysis, sterility is not a requirement for its function. Users should follow standard handling guidelines for diagnostic test kits to ensure accurate and reliable results.

What regulatory pathway was followed for the SpermCheck Vasectomy?

The SpermCheck Vasectomy received FDA 510(k) clearance through the Traditional pathway, classified as a Class II device under product code POV. This classification aligns with its use as a semen analysis device, adhering to regulatory standards outlined in 21 CFR 864.5220. The device is authorized for use in the United States and meets the requirements for hematology-related diagnostic tools.

How should the SpermCheck Vasectomy device be stored?

The SpermCheck Vasectomy device follows standard storage guidelines for diagnostic test kits. While specific storage conditions are not detailed in the provided data, it is generally recommended to store such devices in a cool, dry place, away from direct sunlight or extreme temperatures. Proper storage ensures the integrity and reliability of the test results when used as intended.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SPERMCHECK VASECTOMY (K073039) — FDA 510 (k) | Innolitics, K073039 - SPERMCHECK VASECTOMY | FDA 510 (k), SpermCheck | At-Home Sperm Count Testing for Fertility and Vasectomy, SPERMCHECK VASECTOMY 510(k) K073039 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA 510(k) K073039 24 fields · synced Oct 1, 2026