Cleared Traditional

K071652 - HEMOCUE WBC SYSTEM

K071652 is the FDA 510(k) clearance for HEMOCUE WBC SYSTEM by Hemocue AB. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K071652 · Hemocue AB · Hematology device
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Oct 2007
Decision
129d
Days
Class 2
Risk

K071652 is an FDA 510(k) clearance for the HEMOCUE WBC SYSTEM. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on October 25, 2007 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Hemocue AB devices

Submission Details

510(k) Number K071652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2007
Decision Date October 25, 2007
Days to Decision 129 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
16d slower than avg
Panel avg: 113d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 49
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K071652.
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · Bayer Corp. · Aug 1997
RETICULOCYTE METHOD
K954607 · Bayer Corp. · Aug 1996
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
K930685 · Heraeus Kulzer, Inc. · Jun 1993
QBC HEMACAN HEMATOLOGY SYSTEM
K923121 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1992
COULTER FLOW RETICULOCYTE REAGENT
K885332 · Coulter Electronics, Inc. · Feb 1989
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
K884618 · Nova Biomedical Corp. · Jan 1989