Cleared Traditional

K854368 - CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER

K854368 is an FDA 510(k) clearance for CELL-DYN 1500 MULTI-PARAMETER HEMATOLOG..., 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 64-day FDA review.

K854368 · Abbott Diagnostics · Hematology device
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Jan 1986
Decision
64d
Days
Class 2
Risk

K854368 is an FDA 510(k) clearance for the CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on January 1, 1986 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Diagnostics devices

FDA 510(k) Submission Details - K854368

510(k) Number K854368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date January 01, 1986
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
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 299
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K854368.
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · Technicon Instruments Corp. · Jan 1986
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.
K852988 · Technicon Instruments Corp. · Jan 1986
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY
K852371 · Abbott Diagnostics · Sep 1985
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS
K850354 · Toa Medical Electronics USA, Inc. · May 1985
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -
K844910 · Toa Medical Electronics USA, Inc. · Apr 1985