# K043215: Flowcare PLG CD4 Reagent

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 19, 2005 after 61 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: 3 generations back to K922745 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla, Coulter Corp. (1999) Summary page 1.

## Most influential descendants
- K072869: Pointcare Now System (2008), 0 descendants of its own

## Indications for use
The FlowCARE PLG CD4 Reagent is for use on the Coulter® EPICS®XLTM/XL-MCLTM or equivalent flow cytometer. The reagent kit combines two fluorescent-labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD4 absolute cell count and CD4 lymphocyte percentage in combination with a White Blood Cell (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count TM Fluorospheres as a single platform measurement. The FlowCARE PLG CD4 Reagent provides the ability to measure CD4+ cells by utilizing a pan-leukocyte gating (PLG) approach where CD4+ T-cell enumeration is based on the use of all leukocytes, instead of on lymphocytes only, as the matching common denominator between the hematology generated WBC and the flow cytometric enumeration. A sequential gating strategy is used to include all CD45+ leukocytes and to measure the CD4+% of total leukocyte values generated from this gate.

Source page: https://510kreport.com/device/K043215
Methodology: https://510kreport.com/methodology