Cleared Traditional

K012805 - AUTOMARQER

K012805 is an FDA 510(k) clearance for AUTOMARQER, manufactured by Hamilton Thorne Research. The device is a Class 2 Hematology device with product code POV cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K012805 · Hamilton Thorne Research · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
204d
Days
Class 2
Risk

K012805 is an FDA 510(k) clearance for the AUTOMARQER. Classified as Semen Analysis Device (product code POV), Class II - Special Controls.

Submitted by Hamilton Thorne Research (Beverly, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 204 days - an extended review 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: 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.

FDA 510(k) Submission Details - K012805

510(k) Number K012805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2001
Decision Date March 13, 2002
Days to Decision 204 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
91d slower than avg
Panel avg: 113d · This submission: 204d
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 K012805.
HBA SPERM-HYALURONAN BINDING ASSAY
K032874 · Biocoat, Inc. · Nov 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · Bioshaf , Ltd. · Jul 2003
SQA V, SPERM QUALITY ANALYZER
K021746 · Medical Electronic Systems, LLC · Sep 2002
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
K012805 · AUTOMARQER
Download PDF FDA Summary Hamilton Thorne Resea…