# K962768: Cyto-Stat Trichrome CD45-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Anitbody Reagent W/Isotypic Control

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Jan 6, 1997 after 203 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: 1 generation back to K922745 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922745: Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1, Coulter Immunology (1993) Summary page 1.

## Indications for use
CYTO-STAT® triCHROME™ CD45-FITC/CD4-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent identifies a lymphocyte gate based on CD4S staining (vs. side scatter) and allows simultaneous identification and enumerstion of total CD3+, total CD4+ and dual-stained CD3+/CD4+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MslgG1-RD1/MslgG1-PCS, is used to monitor non-specific binding.

Source page: https://510kreport.com/device/K962768
Methodology: https://510kreport.com/methodology