# K030828: Tetracxp System (Software and System Guide)

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: May 21, 2003 after 68 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922745 (1993). 6 ancestors in all.
6 later devices descend from it; 3 cite it directly.
4 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla, Coulter Corp. (1999) Summary page 1.

## Most influential descendants
- K130373: Navios Flow Cytometer System (2013), 3 descendants of its own
- K162897: Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (2017), 2 descendants of its own
- K183592: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (2019), 1 descendant of its own
- K071681: Cytomics FC 500 MPL Flow Cytometer, Model # 626554 (2007), 1 descendant of its own
- K232600: DxFLEX Flow Cytometer; ClearLLab 10C Panels (2023), 0 descendants of its own

## Recalls of this device
- Jan 12, 2018 · Class I · Z-0471-2019: 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 p
- May 22, 2012 · Class II · Z-0035-2013: 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
- Oct 11, 2007 · Not classified · Z-0129-2009: 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 do
- Aug 20, 2007 · Not classified · Z-1529-2008: 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 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 G
- Jun 29, 2007 · Not classified · Z-0959-2008: 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: Two workflow scenarios associated with renaming regions may produce incorrect results.
- Aug 29, 2006 · Not classified · Z-0419-2007: Two workflow scenarios associated with renaming regions may produce incorrect results.
- Aug 29, 2006 · Not classified · Z-0420-2007: Two workflow scenarios associated with renaming regions may produce incorrect results.
- Jul 26, 2006 · Not classified · Z-0197-2007: 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 p

## Indications for use
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.

Source page: https://510kreport.com/device/K030828
Methodology: https://510kreport.com/methodology