# K060423: Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres

- Pathway: 510(k) (Traditional)
- Applicant: Dakocytomation California, Inc.
- Decided: Aug 15, 2006 after 179 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: 3 generations back to K925274 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974360: Multitest CD3/CD8/CD45/CD4, Becton Dickinson Immunocytometry Systems (1998) Summary page 1.
- K961701: Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) Rpe, Dako Corp. (1996) Summary page 1.
- K955909: Mouse Anti-Human CD3, T-Cell, Fitc & CD8, T-Cell (Suppressor/Cytotoxic) Rpe, Dako Corp. (1996) Summary page 1.
- K964974: Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/Rpe, Dako Corp. (1997) Summary page 1.
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set, Becton Dickinson Immunocytometry Systems (1998) Summary page 1.

## Indications for use
Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660. For In-Vitro Diagnostic Use

Source page: https://510kreport.com/device/K060423
Methodology: https://510kreport.com/methodology