# 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

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter
- Decided: Jun 23, 2017 after 249 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: 5 generations back to K922745 (1993). 9 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K130373: Navios Flow Cytometer System, Beckman Coulter, Inc. (2013) Summary page 7.
- (no number) 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: named in the summary without a submission number

## Most influential descendants
- 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 EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to four fluorescent detection channels using a blue (488 nm) laser and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CDS56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are for use on the COULTER EPICS XI/XL-MCL, Cytomics FC 500, Navios and Navios EX Flow Cytometers. The reagents are also used with the tetraONE System for COULTER EPICS XL/XL-MCL Flow Cytometer, the tetraCXP System for FC 500 Flow Cytometry System, Navios tetra Software for the Navios System, and Navios EX tetra Software for the Navios EX System, Used alone or in combination with the automated systems, the reagents are intended "For In Vitro Diagnostic Use" and allow simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+CD4+, dual CD3+CD8+ and/or total CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PCS. These reagents are 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, Navios and Navios EX Flow Cytometers. Flow-Count Fluorospheres is a fluorescent microsphere reagent for direct determination of lymphocytes and lymphocyte subsets cell population percentages and absolute counts in biological specimens using EPICS XL/XL-MCL, Cytomics FC500, Navios and Navios EX flow cytometry systems as well as CD34+ cell population percentages and absolute counts in biological specimens using EPICS XL/XL-MCL and Cytomics FC500 flow cytometry systems.

Source page: https://510kreport.com/device/K162897
Methodology: https://510kreport.com/methodology