# K182886: Cytomics FC 500 Series (MPL or MCL) Flow Cytometer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter
- Decided: Sep 6, 2019 after 326 days
- Product code: GKZ (Counter, Differential Cell)
- 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). 8 ancestors in all.
No later device cites it as a predicate yet.
4 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071681: Cytomics FC 500 MPL Flow Cytometer, Model # 626554, Beckman Coulter, Inc. (2007) Summary page 5.
- K030828: Tetracxp System (Software and System Guide), Beckman Coulter, Inc. (2003) Summary page 5.

## Indications for use
The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file. The tetraCXP SYSTEM for Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+ and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and CXP software. The systems with CYTO-STAT tetraCHROME CD45-FITC/CD4-PD/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. The systems with CD45-FITC/CD56-PC/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can obtained as well.

Source page: https://510kreport.com/device/K182886
Methodology: https://510kreport.com/methodology