Cleared Traditional

K100341 - SPERMCHECK FERTILITY

K100341 is an FDA 510(k) clearance for SPERMCHECK FERTILITY, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Hematology device with product code POV cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K100341 · Princeton BioMeditech Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
May 2010
Decision
88d
Days
Class 2
Risk

K100341 is an FDA 510(k) clearance for the SPERMCHECK FERTILITY. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 4, 2010 after a review of 88 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K100341

510(k) Number K100341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2010
Decision Date May 04, 2010
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
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 10
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K100341.
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
K202089 · Bonraybio Co., Ltd. · Oct 2020
SwimCount Sperm Quality Test
K183602 · Motilitycount Aps · Jun 2019
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
K180343 · Bonraybio Co., Ltd. · Nov 2018
SPERMCHECK VASECTOMY
K073039 · Princeton BioMeditech Corp. · Jan 2008