# K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Apr 13, 1999 after 84 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: 2 generations back to K922745 (1993). 5 ancestors in all.
14 later devices descend from it; 5 cite it directly.
4 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926124: Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 Mon, Coulter Corp. (1993) Summary page 1.
- K982172: Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col, Coulter Corp. (1998) Summary page 1.
- K963263: Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome CD45-Fitc/CD4-Rdi/CD8-Ecd/CD3-PC5, Coulter Corp. (1997) Summary page 2.

## Most influential descendants
- 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
- K183592: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (2019), 1 descendant 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 with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent combine four-color fluorescent monoclonal antibody reagents, 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 CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+, CD19+, and CD3-/CD56+ lymphocyte population percentages and absolute counts. The system also provides the T4/T8 ratio when using CYTO-STAT® tetraCHROME™ CDA45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent, and total lymphocyte percentage when using CYTO-STAT® tetraCHROME™ CDA45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. CD3+, CD4+, CD8+, and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation. To illustrate, identification of abnormal levels of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with altered white blood cell counts. Altered percentages of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T (CD3+, CD4+, CD8+) and/or B (CD19+) lymphocyte measurements may be useful as aids in monitoring these cellular populations. Identification of abnormal levels of CD4+ immunodeficiency might also aid in the diagnosis and/or prognosis of immunodeficiency disease. For example, infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS), results in profound immunosuppression due predominantly to a selective depletion of the CD4+ lymphocytes that express the receptor for the virus, which is associated with the CD4+ antigen. Progressive clinical and immunologic deterioration generally correlated with a falling CD4+ lymphocyte count. NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells. CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. Used as a four color Lymphocyte Immunophenotyping Panel, CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 also function as a quality control check for a specimen in terms of CD3+ lymphocyte measurement reproducibility within the Panel.

Source page: https://510kreport.com/device/K990172
Methodology: https://510kreport.com/methodology