Cleared Traditional

K983473 - FERTILMARQ TEST KIT

K983473 is the FDA 510(k) clearance for FERTILMARQ TEST KIT by Embryotech Laboratories, Inc.. It is a Class 2 Hematology device (product code POV) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K983473 · Embryotech Laboratories, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
76d
Days
Class 2
Risk

K983473 is an FDA 510(k) clearance for the FERTILMARQ TEST KIT. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Embryotech Laboratories, Inc. (Wilmington, US). The FDA issued a Cleared decision on December 17, 1998 after a review of 76 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 Embryotech Laboratories, Inc. devices

Submission Details

510(k) Number K983473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1998
Decision Date December 17, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 113d · This submission: 76d
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.