Cleared Traditional

K945205 - QBC ACCUTUBE

K945205 is an FDA 510(k) clearance for QBC ACCUTUBE, manufactured by Becton Dickinson Diagnostic Instrument Systems. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K945205 · Becton Dickinson Diagnostic Instrument Systems · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
335d
Days
Class 2
Risk

K945205 is an FDA 510(k) clearance for the QBC ACCUTUBE. 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 September 25, 1995 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Becton Dickinson Diagnostic Instrument Systems devices

FDA 510(k) Submission Details - K945205

510(k) Number K945205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1994
Decision Date September 25, 1995
Days to Decision 335 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
222d slower than avg
Panel avg: 113d · This submission: 335d
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 296
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K945205.
VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
K940003 · Buckman Co., Inc. · Oct 1995
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · Abbott Laboratories · Oct 1995
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
K953448 · Roche Diagnostic Systems, Inc. · Oct 1995
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · Coulter Corp. · Aug 1995
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
K950057 · Becton Dickinson Immunocytometry Systems · Aug 1995
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · Immunotech Corp. · Aug 1995