Cleared Traditional

K081495 - CELL-DYN EMERALD SYSTEM

K081495 is an FDA 510(k) clearance for CELL-DYN EMERALD SYSTEM, manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K081495 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
251d
Days
Class 2
Risk

K081495 is an FDA 510(k) clearance for the CELL-DYN EMERALD SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on February 4, 2009 after a review of 251 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.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K081495

510(k) Number K081495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2008
Decision Date February 04, 2009
Days to Decision 251 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
138d slower than avg
Panel avg: 113d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 226
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K081495.
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
K093394 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2010
SYSMEX MODEL XT-4000I
K091313 · Sysmex America, Inc. · Mar 2010
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K090810 · Microgenics Corp. · Sep 2009
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K081930 · Beckman Coulter, Inc. · Dec 2008
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
K081890 · Sysmex America, Inc. · Oct 2008
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
K081610 · Sysmex America, Inc. · Aug 2008