Cleared Traditional

QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS (K063864) - FDA 510(k) Clearance

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

K063864 · Medical Electronic Systems , Ltd. · Hematology device
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Mar 2007
Decision
87d
Days
Class 2
Risk

K063864 is an FDA 510(k) clearance for the QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Medical Electronic Systems , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 26, 2007 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Electronic Systems , Ltd. devices

Submission Details

510(k) Number K063864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2006
Decision Date March 26, 2007
Days to Decision 87 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
26d faster than avg
Panel avg: 113d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.