Cleared Traditional

K891276 - QBC MALARIA SYSTEM

K891276 is an FDA 510(k) clearance for QBC MALARIA SYSTEM, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K891276 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Aug 1989
Decision
147d
Days
Class 2
Risk

K891276 is an FDA 510(k) clearance for the QBC MALARIA SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 147 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K891276

510(k) Number K891276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1989
Decision Date August 03, 1989
Days to Decision 147 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
34d slower than avg
Panel avg: 113d · This submission: 147d
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 225
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K891276.
SIMULTEST IMK PLUS(TM)
K900078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1990
COULTER JT3
K896873 · Coulter Corp. · Mar 1990
TECHNICON H*2(TM) SYSTEM
K900593 · Technicon Instruments Corp. · Mar 1990
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · Abbott Diagnostics · Apr 1989
COULTER 5P CONTROL
K885028 · Coulter Electronics, Inc. · Feb 1989