Cleared Traditional

K060423 - CYAN DXD

K060423 is the FDA 510(k) clearance for CYAN DXD by Dakocytomation California, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K060423 · Dakocytomation California, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
179d
Days
Class 2
Risk

K060423 is an FDA 510(k) clearance for the CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Dakocytomation California, Inc. (Carpinteria, US). The FDA issued a Cleared decision on August 15, 2006 after a review of 179 days - an extended review 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: 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 Dakocytomation California, Inc. devices

Submission Details

510(k) Number K060423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2006
Decision Date August 15, 2006
Days to Decision 179 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
66d slower than avg
Panel avg: 113d · This submission: 179d
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 K060423.
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
K071681 · Beckman Coulter, Inc. · Oct 2007
BC-3200 AUTO HEMATOLOGY ANALYZER
K063407 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2007
COULTER LH 780 HEMATOLOGY ANALYZER
K061616 · Beckman Coulter, Inc. · Oct 2006
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K061574 · Beckman Coulter, Inc. · Jul 2006
CELL-DYN RUBY SYSTEM
K061667 · Abbott Laboratories · Jul 2006
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
K052905 · Beckman Coulter, Inc. · Nov 2005