Cleared Traditional

K955504 - QBC ACCUREAD SYSTEM

K955504 is the FDA 510(k) clearance for QBC ACCUREAD SYSTEM by Becton Dickinson Diagnostic Instrument Systems. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K955504 · Becton Dickinson Diagnostic Instrument Systems · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
66d
Days
Class 2
Risk

K955504 is an FDA 510(k) clearance for the QBC ACCUREAD SYSTEM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Becton Dickinson Diagnostic Instrument Systems (Sparks, US). The FDA issued a Cleared decision on February 5, 1996 after a review of 66 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 Becton Dickinson Diagnostic Instrument Systems devices

Submission Details

510(k) Number K955504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date February 05, 1996
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 113d · This submission: 66d
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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K955504.
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
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MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · Dako Corp. · Mar 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · Coulter Corp. · Feb 1996
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/
K945212 · Dako Corp. · Jan 1996
IMAGN(TM) 2000 SYSTEM
K945756 · Buckman Co., Inc. · Dec 1995
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
K954188 · Immunotech Corp. · Nov 1995