Cleared Traditional

K011679 - FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY

K011679 is an FDA 510(k) clearance for FERTILMARQ HOME DIAGNOSTIC SCREENING TE..., manufactured by Embryotech Laboratories, Inc.. The device is a Class 2 Hematology device with product code POV cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K011679 · Embryotech Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
77d
Days
Class 2
Risk

K011679 is an FDA 510(k) clearance for the FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Embryotech Laboratories, Inc. (Wayland, US). The FDA issued a Cleared decision on August 15, 2001 after a review of 77 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

FDA 510(k) Submission Details - K011679

510(k) Number K011679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date August 15, 2001
Days to Decision 77 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
36d faster than avg
Panel avg: 113d · This submission: 77d
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 16
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K011679.
Trak Male Fertility Testing System
K153683 · Sandstone Diagnostics, Inc. · May 2016
SPERMCHECK FERTILITY
K100341 · Princeton BioMeditech Corp. · May 2010
SPERMCHECK VASECTOMY
K073039 · Princeton BioMeditech Corp. · Jan 2008
AUTOMARQER
K990184 · Hamilton Thorne Research · Mar 1999
FERTILMARQ TEST KIT
K983473 · Embryotech Laboratories, Inc. · Dec 1998