Cleared Traditional

HEMOCUE WBC SYSTEM (K071652) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071652 · Hemocue AB · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 129
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K071652.
QBC HEMACAN HEMATOLOGY SYSTEM
K923121 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1992
FACSMATE SAMPLE HANDLING DEVICE
K885132 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1988
RETICCOUNT SOFTWARE
K880636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
K872166 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
FACS ANALYZER
K832420 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983