Cleared Special

K071681 - CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554

K071681 is an FDA 510(k) clearance for CYTOMICS FC 500 MPL FLOW CYTOMETER, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Special 510(k) pathway after a 107-day FDA review.

K071681 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
107d
Days
Class 2
Risk

K071681 is an FDA 510(k) clearance for the CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on October 4, 2007 after a review of 107 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071681

510(k) Number K071681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2007
Decision Date October 04, 2007
Days to Decision 107 days
Submission Type Special
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
6d faster than avg
Panel avg: 113d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K071681.
POINTCARE NOW SYSTEM
K072869 · Pointcare Technologies, Inc. · Jan 2008
D3 HEMATOLOGY ANALYZER, MODEL D3
K071562 · Drew Scientific, Inc. · Dec 2007
SYSMEX XE-5000
K071967 · Sysmex America, Inc. · Nov 2007
BC-3200 AUTO HEMATOLOGY ANALYZER
K063407 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2007
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
K071141 · Bd Biosciences · Jun 2007
BD TRITEST CD3/CD4/CD45, MODEL 340383
K071143 · Bd Biosciences · Jun 2007
K071681 · CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
Download PDF FDA Summary Beckman Coulter, Inc.