Cleared Traditional

K021746 - SQA V, SPERM QUALITY ANALYZER

K021746 is an FDA 510(k) clearance for SQA V, manufactured by Medical Electronic Systems, LLC. The device is a Class 2 Hematology device with product code POV cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K021746 · Medical Electronic Systems, LLC · Hematology device
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Sep 2002
Decision
115d
Days
Class 2
Risk

K021746 is an FDA 510(k) clearance for the SQA V, SPERM QUALITY ANALYZER. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Medical Electronic Systems, LLC (Beverly Hills, US). The FDA issued a Cleared decision on September 20, 2002 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K021746

510(k) Number K021746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date September 20, 2002
Days to Decision 115 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 113d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

POV Device Classification - Class 2, Special Controls

Product Code POV Semen Analysis Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - POV Semen Analysis Device

All 27
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K021746.
FERTELL MALE FERTILITY TEST
K041039 · Genosis , Ltd. · Jul 2004
HBA SPERM-HYALURONAN BINDING ASSAY
K032874 · Biocoat, Inc. · Nov 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · Bioshaf , Ltd. · Jul 2003
AUTOMARQER
K012805 · Hamilton Thorne Research · Mar 2002
SQA, SPERM QUALITY ANALYZER
K012352 · Medical Electronic Systems, LLC · Sep 2001
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
K011679 · Embryotech Laboratories, Inc. · Aug 2001
K021746 · SQA V, SPERM QUALITY ANALYZER
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