510(k) · Cleared
Recalled · Class I · 2018Tetracxp System (Software and System Guide)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · GKZ Counter, Differential Cell
Cleared on May 21, 2003 as substantially equivalent to K990172 (Coulter Corp., 1999) after a 68-day review. Its family tree reaches back 3 generations to 1993. 4 of the 13 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 10 times, including a Class I recall.
- Decided
- May 21, 2003
- Review
- 68 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 10 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922745 (1993). 6 ancestors in all. 6 later devices descend from it, 3 citing it directly. 4 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- 2 generations backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- 1 generation backK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- This deviceK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- Descendant · 2 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 · 1 of its ownK183592 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios…Beckman Coulter · 2019
- Descendant · cites it directly · 1 of its ownK071681 Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK232600 DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 2023 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K130373Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013 · cites it directly3descendants
- K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter · 2017 · 2 generations on2descendants
- K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter · 2019 · 2 generations on1descendant
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · cites it directly1descendant
- K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| −2 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| −1 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| 0 (this device) | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | — |
| +1 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| +2 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2… | Beckman Coulter | 2017 | — |
| +2 | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow… | Beckman Coulter | 2019 | — |
| +1 | K071681 | Cytomics FC 500 MPL Flow Cytometer, Model # 626554 | Beckman Coulter, Inc. | 2007 | Class I |
| +3 | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023 | 1 |
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 |
|---|---|---|
| 2007 | 1 | 1 |
| 2013 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Summary page 1…oclonal Antibody Reagent and CYTO-STAT tetraCHROME CD-45-FITC/CD56-RDl/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. FDA 510(k)Number(s): K990172 3.0 Device Description tetraCXP SYSTEM for the Cytomics FC 500 with CXP Software consists of CYTO-ST… | 1999 |
What descends from it? (6)
3 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-0471-2019 | 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. |
| May 22, 2012 | Class II | Z-0035-2013 | Process control | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and… |
| Oct 11, 2007 | Not classified | Z-0129-2009 | Software design | Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user… |
| Aug 20, 2007 | Not classified | Z-1529-2008 | Software design | Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. |
| Aug 1, 2007 | Not classified | Z-0455-2009 | Software design | Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal… |
| Jun 29, 2007 | Not classified | Z-0959-2008 | Software design | Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data. |
| Aug 29, 2006 | Not classified | Z-0418-2007 | Other | Two workflow scenarios associated with renaming regions may produce incorrect results. |
| Aug 29, 2006 | Not classified | Z-0419-2007 | Other | Two workflow scenarios associated with renaming regions may produce incorrect results. |
| Aug 29, 2006 | Not classified | Z-0420-2007 | Other | Two workflow scenarios associated with renaming regions may produce incorrect results. |
| Jul 26, 2006 | Not classified | Z-0197-2007 | Other | Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and… |
The 5 latest of 10 recalls; the web page lists all.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K130373 (Beckman Coulter, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K990172.
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 tetraCXP Software for Cytomics FC 500 flow cytometry systems and CYTO-STAT tetraCHROMETMCD45-FITC/CD4-RDl/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROMETM CD45-FlTC/CD56-RDl/CD19-ECD/CD3-PC5 MonoclonalAntibody Reagents combine fourcolor fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using Cytomics FC 500 flow cytometry…
Read the full statement (154 words)
The tetraCXP Software for Cytomics FC 500 flow cytometry systems and CYTO-STAT tetraCHROMETMCD45-FITC/CD4-RDl/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROMETM CD45-FlTC/CD56-RDl/CD19-ECD/CD3-PC5 MonoclonalAntibody Reagents combine fourcolor fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using Cytomics FC 500 flow cytometry systems with CXP Software.
The system with CMO-STAT tetraCHROME CD45-FITC/CD4-RDllCD8-ECD/CD3-PC5 is intended “For In Vitro Diagnostic Use” and allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ T lymphocyte population percentages and absolute counts.
The system with CMO-STAT tetraCHROME CD45-FITC/CD56-RDl/CD19-ECD/CD3-PC5 is intended “For In Vitro Diagnostic Use” and allows simultaneous identification and enumeration of total CD3+ (T), CD19+ (B), and CD3-/CD56+ (NK) lymphocyte population percentages and absolute counts. This reagent reflects the distribution of the three major subsets comprising the lymphocyte population upon which other lymphocyte enumeration studies are based and provides the total lymphocyte percentage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030828: Tetracxp System (Software and System Guide).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030828
Report an extraction error
Are you the manufacturer?
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