Cleared Traditional

QWIKCHECK-BEADS (K041600) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041600 · Medical Electronics Systems , Ltd. · Hematology device
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Jul 2004
Decision
43d
Days
Class 2
Risk

K041600 is an FDA 510(k) clearance for the QWIKCHECK-BEADS. Classified as Material, Quality Control, Semen Analysis (product code NRF), Class II - Special Controls.

Submitted by Medical Electronics Systems , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on July 27, 2004 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K041600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date July 27, 2004
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRF Material, Quality Control, Semen Analysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
Definition A Semen Analysis Quality Control Material Is A Device Used To Determine The Accuracy And Precision Of Manual, Semiautomated, And Automated Determinations Of Semen Analysis Parameters Such As Ph, Sperm Concentration, Total Sperm Number, Motility, Morphology, Vitality, And White Blood Cells.
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.