Cleared Traditional

K874147 - QBC BLOOD BANK SYSTEM

K874147 is the FDA 510(k) clearance for QBC BLOOD BANK SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K874147 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Jan 1988
Decision
90d
Days
Class 2
Risk

K874147 is an FDA 510(k) clearance for the QBC BLOOD BANK 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 January 11, 1988 after a review of 90 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

Submission Details

510(k) Number K874147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date January 11, 1988
Days to Decision 90 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
23d faster than avg
Panel avg: 113d · This submission: 90d
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 225
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K874147.
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · Coulter Electronics, Inc. · Mar 1988
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.
K874838 · Coulter Electronics, Inc. · Feb 1988
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
K874763 · Instrumentation Laboratory CO · Feb 1988
QBC SYSTEM HEMOGLOBIN
K874427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · Toa Medical Electronics USA, Inc. · Nov 1987
CELL-DYN 610 HEMATOLOGY ANALYZER
K872761 · Abbott Diagnostics · Aug 1987