# K982172: Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Sep 24, 1998 after 97 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 K926124 (1993). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
3 of 18 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.

## 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

## Indications for use
CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MslgG1-FITC, is used to monitor nonspeécific staining. CYTO-STAT®COULTER CLONE® MsIgG1-RD1/MslgG1-PCS5 Isotypic Control is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® or CYTO-STAT®/COULTER CLONE® Monoclonal Antibody Reagents comprised of two MslgGl subclass monoclonal antibodies conjugated to RD1 and FITC. CD3+ 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+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4/T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations. 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. As part of a Two Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT®/COULTER® CLONE® CD3(IgG1)-FITC/B4-RD1, CYTO-STAT® CD3-FITC/CD56-RD1 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

Source page: https://510kreport.com/device/K982172
Methodology: https://510kreport.com/methodology