SQA V, Sperm Quality Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021746 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 SQA V, Sperm Quality Analyzer is a point-of-care, electro-optical device designed for semen analysis. It provides on-screen visualization and image freezing capabilities to assess sperm count, morphology, motility, and additional parameters.
The device is supplied by Medical Electronic Systems, LLC and received FDA 510(k) clearance (K021746) on September 20, 2002. It is classified as a Class II device under regulation number 864.5220 with product code POV and is intended for use in hematology-related testing environments.
Frequently asked questions
What is the SQA V Sperm Quality Analyzer used for?
The SQA V Sperm Quality Analyzer is designed for semen analysis, enabling assessment of sperm count, morphology, motility, and additional parameters through on-screen visualization and image freezing capabilities in point-of-care settings.
How is the SQA V Sperm Quality Analyzer supplied and what is its intended use environment?
The device is supplied by Medical Electronic Systems, LLC and is intended for use in hematology-related testing environments, as indicated by its classification under regulation number 864.5220 and product code POV for semen analysis devices.
Is the SQA V Sperm Quality Analyzer a single-use or reusable device, and does it require sterilization?
The device data does not specify whether the SQA V is single-use or reusable, nor does it mention sterilization requirements; therefore, no conclusion can be drawn about its reusability or sterility based on the provided information.
What regulatory pathway was used for the SQA V Sperm Quality Analyzer and when was it cleared?
The SQA V Sperm Quality Analyzer received FDA 510(k) clearance (K021746) on September 20, 2002, through a traditional submission process, and was found substantially equivalent to a predicate device.
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: Home - Medical Electronic Systems, SQA-V Gold - Medical Electronic Systems, SQA V, SPERM QUALITY ANALYZER (K021746) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021746 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Electronic Systems, LLC
Sources (1)
- FDA 510(k) K021746 24 fields · synced Sep 27, 2026