510(k) · Cleared
Recalled · Class I · 2018Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome CD45-Fitc/CD4-Rdi/CD8-Ecd/CD3-PC5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · GKZ Counter, Differential Cell
Cleared on Jan 22, 1997 as substantially equivalent to K922745 (Coulter Immunology, 1993) and 1 other predicate after a 155-day review. Its family tree reaches back 1 generation to 1993. 4 of the 18 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jan 22, 1997
- Review
- 155 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922745 (1993). 2 ancestors in all. 15 later devices descend from it, 1 citing it directly. 4 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- This deviceK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997
- Descendant · cites it directly · 14 of its ownK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- Descendant · 4 generations on · 2 of its ownK162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer…Beckman Coulter · 2017
- Descendant · 2 generations on · 2 of its ownK030408 Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody…Beckman Coulter, Inc. · 2003 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · cites it directly14descendants
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 2 generations on6descendants
- K130373Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013 · 3 generations on3descendants
- K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter · 2017 · 4 generations on2descendants
- K030408Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…Beckman Coulter, Inc. · 2003 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| 0 (this device) | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | — |
| +1 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| +2 | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | Class I |
| +3 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| +4 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2… | Beckman Coulter | 2017 | — |
| +2 | K030408 | Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent… | Beckman Coulter, Inc. | 2003 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 1 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
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.
4 devices in this family have a Class I recall. 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 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Summary page 1…al- positive CD3+/CD8+ T lymphocytes percentages and absolute counts. The system also provides the T4/T8 ratio. Substantial Equivalence: 510(k) Premarket Notification: K922745 CyTo-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T4-RD1 Monoclonal Antibody Reagent 510(k) Premarket Notification: K922744 CYTO-STAT®/CO… | 1993 |
| * | K922744 | Cyto-Stat/Coulter Clone CD 3(IGG1)-Fitc/T8-RD1Summary page 1…stantial Equivalence: 510(k) Premarket Notification: K922745 CyTo-STAT®/COULTER CLONE® CD3(IgG1)-FITC/T4-RD1 Monoclonal Antibody Reagent 510(k) Premarket Notification: K922744 CYTO-STAT®/COULTER CLLONE® CD3(IgG1)-FITC/T8-RD1 Monoclonal Antibody Reagent Product Differences: CD45/CD4/CD8/CD3, CD3/T4 and C… | 1993 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… Class I | 1999 | 14 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2018 | Class I | Z-0472-2019 | Nonconforming Material/Component | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems and CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent combines a four-color fluorescent monoclonal antibody reagent, four quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro…
Read the full statement (93 words)
The tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems and CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent combines a four-color fluorescent monoclonal antibody reagent, four quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro Diagnostic Use” and allows simultaneous identification and enumeration of total CD4+, total CD8+, total CD3+, dual-positive CD3+/CD4+ and dual-positive CD3+/CD8+ T lymphocytes percentages and absolute counts. The system also provides the T4/T8 ratio.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963263: Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome CD45-Fitc/CD4-Rdi/CD8-Ecd/CD3-PC5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963263
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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