510(k) · Cleared
Recalled · Class I · 2018Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla
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 Apr 13, 1999 as substantially equivalent to K926124 (Coulter Corp., 1993) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1993. 4 of the 20 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Apr 13, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922745 (1993). 5 ancestors in all. 14 later devices descend from it, 5 citing it directly. 4 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- 1 generation backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- This deviceK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999
- Descendant · cites it directly · 6 of its ownK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer…Beckman Coulter · 2017
- Descendant · cites it directly · 2 of its ownK030408 Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody…Beckman Coulter, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 1 of its ownK183592 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios…Beckman Coulter · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · cites it directly6descendants
- K130373Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013 · 2 generations on3descendants
- K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter · 2017 · 3 generations on2descendants
- K030408Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…Beckman Coulter, Inc. · 2003 · cites it directly2descendants
- K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| −1 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| 0 (this device) | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | — |
| +1 | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | Class I |
| +2 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| +3 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2… | Beckman Coulter | 2017 | — |
| +1 | K030408 | Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent… | Beckman Coulter, Inc. | 2003 | 4 |
| +3 | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow… | Beckman Coulter | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K926124 | Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 MonSummary page 1…TAT® tetraCHROME™ * CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Science Serving Humanity Substantial Equivalence: 510(k) Premarket Notification: K926124 CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/B4-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MslgGl-RD1/MslgGl-FIT… | 1993 |
| * | K982172 | Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…Summary page 1…tibody Reagent with CYTO-STAT®/COULTER CLONE® MslgGl-RD1/MslgGl-FITC & CYTO-STAT®/COULTER CLONE® Mo2-RD1/KC56 (T-200)-FITC Gating Reagent 510(k) Premarket Notification. K982172 CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MslgGl-RDI/MslgGl-FITC & CYTO-STAT®/COU… | 1998 |
| * | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Summary page 2…E® MslgGl-RDI/MslgGl-FITC & CYTO-STAT®/COULTER CLONE® Mo2-RD1/KC56 (T-200)-FITC Gating Reagent 4232216-F R 6-97 [Note: See 5/0(k) Premarket Notification K963263 for information pertaining to tetraONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-R… | 1997 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K030828 (Beckman Coulter, Inc., 2003) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K926124.
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 with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent combine four-color fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL™…
Read the full statement (382 words)
The tetraONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent combine four-color fluorescent monoclonal antibody reagents, 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 CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+, CD19+, and CD3-/CD56+ lymphocyte population percentages and absolute counts. The system also provides the T4/T8 ratio when using CYTO-STAT® tetraCHROME™ CDA45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent, and total lymphocyte percentage when using CYTO-STAT® tetraCHROME™ CDA45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent.
CD3+, CD4+, CD8+, and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation.
To illustrate, identification of abnormal levels of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with altered white blood cell counts. Altered percentages of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T (CD3+, CD4+, CD8+) and/or B (CD19+) lymphocyte measurements may be useful as aids in monitoring these cellular populations.
Identification of abnormal levels of CD4+ immunodeficiency might also aid in the diagnosis and/or prognosis of immunodeficiency disease. For example, infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS), results in profound immunosuppression due predominantly to a selective depletion of the CD4+ lymphocytes that express the receptor for the virus, which is associated with the CD4+ antigen. Progressive clinical and immunologic deterioration generally correlated with a falling CD4+ lymphocyte count.
NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.
CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. Used as a four color Lymphocyte Immunophenotyping Panel, CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 also function as a quality control check for a specimen in terms of CD3+ lymphocyte measurement reproducibility within the Panel.
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/K990172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990172
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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