# K982166: Cyto-Stat Trichrome CD45-Fitc/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome CD45-Fitc/MSIGG1-RD1

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Nov 5, 1998 after 139 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: 2 generations back to K926124 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982172: Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col, Coulter Corp. (1998). Cleared while this submission was under review Summary page 1.

## Indications for use
CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three 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® triCHROME™ CD45-FITC/MslgG1-RD1/MslgG1-PCS, is used to monitor nonspecific staining. CYTO-STAT® triCHROME™ CD45-FITC/MslgG1-RD1/MslgG1-PCS Isotypic Control is a three-color fluorescent reagent comprised of three 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® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MslgG1 subclass monoclonal antibodies conjugated to RD1 and PCS. CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate inmune competency ufiderlying 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 Three Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT® triCHROMET™ CD45-FITC/CD19-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 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/K982166
Methodology: https://510kreport.com/methodology