Cleared Traditional

K853029 - TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA

K853029 is an FDA 510(k) clearance for TECHNICON H*1 SYSTEM LOBULARITY INDX/LF..., manufactured by Technicon Instruments Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K853029 · Technicon Instruments Corp. · Hematology device
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Jan 1986
Decision
190d
Days
Class 2
Risk

K853029 is an FDA 510(k) clearance for the TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 190 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K853029

510(k) Number K853029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1985
Decision Date January 24, 1986
Days to Decision 190 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
77d slower than avg
Panel avg: 113d · This submission: 190d
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 K853029.
SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM
K855116 · Toa Medical Electronics USA, Inc. · Feb 1986
SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM
K855117 · Toa Medical Electronics USA, Inc. · Feb 1986
TECHNICON H*1 SYSTEM (MPXI)
K853027 · Technicon Instruments Corp. · Feb 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 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · Abbott Diagnostics · Jan 1986