Cleared Traditional

K153683 - Trak Male Fertility Testing System

K153683 is the FDA 510(k) clearance for Trak Male Fertility Testing System by Sandstone Diagnostics, Inc.. It is a Class 2 Hematology device (product code POV) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K153683 · Sandstone Diagnostics, Inc. · Hematology device
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May 2016
Decision
146d
Days
Class 2
Risk

K153683 is an FDA 510(k) clearance for the Trak Male Fertility Testing System. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Sandstone Diagnostics, Inc. (Livermore, US). The FDA issued a Cleared decision on May 16, 2016 after a review of 146 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sandstone Diagnostics, Inc. devices

Submission Details

510(k) Number K153683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2015
Decision Date May 16, 2016
Days to Decision 146 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
33d slower than avg
Panel avg: 113d · This submission: 146d
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.

Regulatory Peers - POV Semen Analysis Device

All 11
Devices cleared under the same product code (POV) and FDA review panel - the closest regulatory comparables to K153683.
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 FERTILITY
K100341 · Princeton BioMeditech Corp. · May 2010
SPERMCHECK VASECTOMY
K073039 · Princeton BioMeditech Corp. · Jan 2008