510(k) Report

510(k) · Cleared

Cleared

Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres

K060423510(k) TraditionalCleared Aug 15, 2006179-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dakocytomation California, Inc. · GKZ Counter, Differential Cell

Cleared on Aug 15, 2006 as substantially equivalent to K974360 (Becton Dickinson Immunocytometry Systems, 1998) and 4 other predicates after a 179-day review. Its family tree reaches back 3 generations to 1994.

Decided
Aug 15, 2006
Review
179 days
Class
Class II
Product code
GKZ
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K925274 (1994). 17 ancestors in all, the oldest K913192 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 4 other ancestors1996: 5 other ancestors1994: 3 other ancestors1992: 1 other ancestorK925274 · Autocomp (TM) Software and Calibrite (TM) Beads · Becton Dickinson Immunocytometry Systems · 1994K961623 · Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads · Becton Dickinson Monoclonal Center · 1996K973483 · Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set · Becton Dickinson Immunocytometry Systems · 1998 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 3 other ancestors K973483 · Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set · Becton Dickinson Immunocytometry Systems · 1998 · recalledK961623 · Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads · Becton Dickinson Monoclonal Center · 1996K925274 · Autocomp (TM) Software and Calibrite (TM) Beads · Becton Dickinson Immunocytometry Systems · 19940
  1. Root · 3 generations backK925274 Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems · 1994
  2. 2 generations backK961623 Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996
  3. 1 generation backK973483 Facscomp Software and Calibrite Beads for Use in Flow Cytometer…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
  4. This deviceK060423 Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and…Dakocytomation California, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K925274Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems1994—
−2K961623Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center1996—
−1K973483Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetBecton Dickinson Immunocytometry Systems19981
0 (this device)K060423Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and FluorospheresDakocytomation California, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199430
199650
199740
199810
FIG. 1 — Lineage of K060423, 1994–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GKZ device

  1. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K974360Multitest CD3/CD8/CD45/CD4
Summary page 1
…Hematology and Pathology Devices Panel Division of Clinical Laboratory Devices. Predicate Devices: B-D FACS Calibur, K974360 Dako CD3/CD4 (FR875), K961701 Dako CD3/CD8 (FR881), K955909…
Becton Dickinson Immunocytometry Systems1998—
*K961701Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) Rpe
Summary page 1
…Division of Clinical Laboratory Devices. Predicate Devices: B-D FACS Calibur, K974360 Dako CD3/CD4 (FR875), K961701 Dako CD3/CD8 (FR881), K955909 Dako CD45/CD14 (FR700), K964974…
Dako Corp.1996—
*K955909Mouse Anti-Human CD3, T-Cell, Fitc & CD8, T-Cell (Suppressor/Cytotoxic) Rpe
Summary page 1
…es. Predicate Devices: B-D FACS Calibur, K974360 Dako CD3/CD4 (FR875), K961701 Dako CD3/CD8 (FR881), K955909 Dako CD45/CD14 (FR700), K964974 BD CaIBRITE Beads, K973483 Device Des…
Dako Corp.1996—
*K964974Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/Rpe
Summary page 1
…Dako CD3/CD4 (FR875), K961701 Dako CD3/CD8 (FR881), K955909 Dako CD45/CD14 (FR700), K964974 BD CaIBRITE Beads, K973483 Device Description: The Dako CyAnT " DXD device is a bench-top flow cyt…
Dako Corp.1997—
*K973483Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set
Summary page 1
…1 Dako CD3/CD8 (FR881), K955909 Dako CD45/CD14 (FR700), K964974 BD CaIBRITE Beads, K973483 Device Description: The Dako CyAnT " DXD device is a bench-top flow cytometer system relying on multiple (up to…
Becton Dickinson Immunocytometry Systems19981

Also cleared against K974360: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
  • 5 of the 17 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K974360.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
2007high 3,338 (2016) · low 77 (2025)2025

MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

What is it indicated for?

Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660.

For In-Vitro Diagnostic Use

Indications for use as stated in the FDA summary.

Also cleared against K974360

6 other devices cite the same predicate.

  • K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical…Becton, Dickinson and Company · 201717 recalls
  • K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol…Beckman Coulter, Inc. · 20156 recalls
  • K101911Immuknow-the Cylex Immune Cellfunction AssayCylex, Inc. · 2010
  • K053497Guava EZCD4 SystemGuava Technologies, Inc. · 2006
  • K013169Immune Cell Function AssayCylex, Inc. · 2002
  • K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems · 19981 recall

More from Dakocytomation California, Inc.

2 FDA decisions under this applicant name. See the company

  • K042884Dakocytomation ER/PR Pharmdx KitDakocytomation California, Inc. · 2005

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K060423 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060423: Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060423

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026