# K130373: Navios Flow Cytometer System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 18, 2013 after 216 days
- Product code: OYE (Flow Cytometric Reagents And Accessories.)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922745 (1993). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030828: Tetracxp System (Software and System Guide), Beckman Coulter, Inc. (2003) Summary page 1.
- K944751: Coulter Flow Set, Coulter Corp. (1994) Summary page 1.

## Most influential descendants
- 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
- K232600: DxFLEX Flow Cytometer; ClearLLab 10C Panels (2023), 0 descendants of its own

## Indications for use
The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It can be used in conjunction with the following monoclonal antibody reagents and software package: -CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents. These reagents provide identification and enumeration of CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Absolute counts may be determined by the Navios flow cytometer using Flow-Count Fluorospheres (single platform technology method) or separate hematology results (dual platform method). These reagents are indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency. -Navios tetra Software for automated analysis and results with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents. Navios Software may be installed on an independent computer workstation for off-line analysis of listmode files generated by the Navios Flow Cytometer with the monoclonal antibody reagents and software package listed above. The off-line analysis must be performed in accordance with the product labeling. The Navios tetra Software is intended for use as an in vitro diagnostic device for immunophenotyping with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents on the Navios Flow Cytometer. It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Absolute counts may be determined by the Navios flow cytometer using Flow-Count Fluorospheres (single platform technology method) or separate hematology results (dual platform method). It is indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency. Flow-Set Pro Fluorospheres is a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors (FL1-4) on the Cytomics FC 500 and Navios Flow Cytometers.

Source page: https://510kreport.com/device/K130373
Methodology: https://510kreport.com/methodology