Cleared Traditional

QBC CENTRIFUGAL HEMATOLOGY SYSTEM (K854242) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854242 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Jan 1986
Decision
72d
Days
Class 2
Risk

K854242 is an FDA 510(k) clearance for the QBC CENTRIFUGAL HEMATOLOGY SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on January 1, 1986 after a review of 72 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K854242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date January 01, 1986
Days to Decision 72 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
41d faster than avg
Panel avg: 113d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 108
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K854242.
TECHNICON H*1 SYSTEM (MPXI)
K853027 · Technicon Instruments Corp. · Feb 1986
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 ANALYZER
K844645 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1985
TECHNICON H*1 SYSTEM
K842636 · Technicon Instruments Corp. · Jul 1984
FACS ANALYZER
K840195 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984