# K964618: Cyto-Stat Trichrome CD8-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Msiggi-Fitc/Msiggi-RD1

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Dec 23, 1996 after 69 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 K950742 (1995). 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)
- K950742: Cyto-Stat/Coulter Clone CD3-Ecd/T4-RD1/T8-Fitc Monoclonal Antiboey Reagent, Coulter Corp. (1995) Summary page 1.

## Indications for use
CYTO-STAT® triCHROME™ CD8-FITC/CD4-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+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ MslgGl-FITC/MsIgG1-RD1/MsIgG1-PCS, is used to monitor nonspecific staining. CYTO-STAT® triCHROME™ MsIgG1-FITC/MsIgG1-RD1/MslgG1-PC5 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™ CDS8-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent to identify and enumerate total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry.

Source page: https://510kreport.com/device/K964618
Methodology: https://510kreport.com/methodology