Cleared Traditional

K830451 - QBC CENTRIFUGAL HEMATOLOGY SYS

K830451 is the FDA 510(k) clearance for QBC CENTRIFUGAL HEMATOLOGY SYS by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K830451 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
71d
Days
Class 2
Risk

K830451 is an FDA 510(k) clearance for the QBC CENTRIFUGAL HEMATOLOGY SYS. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 27, 1983 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 K830451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date April 27, 1983
Days to Decision 71 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
42d faster than avg
Panel avg: 113d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 82
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K830451.
SYSMEX CC-130
K830505 · Toa Medical Electronics USA, Inc. · May 1983
SYSMEX CC-150
K830506 · Toa Medical Electronics USA, Inc. · May 1983
SYSMEX CC-180
K830508 · Toa Medical Electronics USA, Inc. · May 1983
PROFILE 750 BLOOD CELL COUNTER
K823886 · Mallinckrodt Critical Care · Mar 1983
HEMATOLOGY ANALYZER
K823344 · Abbott Diagnostics · Dec 1982
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758 · Toa Medical Electronics USA, Inc. · Oct 1982