Cleared Traditional

K961439 - ABBOTT CELL-DYN 4000 SYSTEM

K961439 is an FDA 510(k) clearance for ABBOTT CELL-DYN 4000 SYSTEM, manufactured by Abbott Diagnostics. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K961439 · Abbott Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
186d
Days
Class 2
Risk

K961439 is an FDA 510(k) clearance for the ABBOTT CELL-DYN 4000 SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Diagnostics (Santa Clara, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 186 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 Diagnostics devices

FDA 510(k) Submission Details - K961439

510(k) Number K961439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date October 18, 1996
Days to Decision 186 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
73d slower than avg
Panel avg: 113d · This submission: 186d
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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K961439.
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CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955715 · Abbott Laboratories · Oct 1996
RETICULOCYTE METHOD, RBC INDICES
K954594 · Bayer Corp. · Aug 1996
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
K961278 · Coulter Corp. · Jul 1996