Cleared Traditional

K983473 - FERTILMARQ TEST KIT

K983473 is an FDA 510(k) clearance for FERTILMARQ TEST KIT, 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 76-day FDA review.

K983473 · Embryotech Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K983473

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
Combination Product No
PCCP Authorized No
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.

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 K983473.
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
AUTOMARQER
K990184 · Hamilton Thorne Research · Mar 1999
SEMEN ANALYSIS KIT
K915229 · Humagen Fertility Diagnostics, Inc. · Aug 1994
SQA
K894949 · United Medical Systems, Inc. · Dec 1989
CTS-3060 AUTOMATED SEMEN ANALYZER
K881765 · Motion Analysis Corp. · Feb 1989
K983473 · FERTILMARQ TEST KIT
Download PDF FDA Summary Embryotech Laboratori…