# K963263: Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome CD45-Fitc/CD4-Rdi/CD8-Ecd/CD3-PC5

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Jan 22, 1997 after 155 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922745 (1993). 2 ancestors in all.
15 later devices descend from it; 1 cites it directly.
4 of 18 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.
- K922744: Cyto-Stat/Coulter Clone CD 3(IGG1)-Fitc/T8-RD1, Coulter Immunology (1993) Summary page 1.

## Most influential descendants
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla (1999), 14 descendants of its own
- K030828: Tetracxp System (Software and System Guide) (2003), 6 descendants of its own
- K130373: Navios Flow Cytometer System (2013), 3 descendants of its own
- 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
- K030408: Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat Tetrachrom CD45-Fitc/CD56-PE/CD19-a (2003), 2 descendants of its own

## Recalls of this device
- Jan 12, 2018 · Class I · Z-0472-2019: A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact p

## Indications for use
The tetraONE™ SYSTEM for EPICS® XL Flow Cytometry Systems and CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent combines a four-color fluorescent monoclonal antibody reagent, four quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using EPICS® XL Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro Diagnostic Use” and allows simultaneous identification and enumeration of total CD4+, total CD8+, total CD3+, dual-positive CD3+/CD4+ and dual-positive CD3+/CD8+ T lymphocytes percentages and absolute counts. The system also provides the T4/T8 ratio.

Source page: https://510kreport.com/device/K963263
Methodology: https://510kreport.com/methodology