# K081526: Flowcare TLG Reagent

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 14, 2008 after 73 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.
No later device cites it as a predicate yet.
2 of 7 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.

## Indications for use
The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD34, CD3+CD4+ and CD3+CD8+ 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-CountTM Fluorospheres as a single platform measurement. The FlowCARE TLG Reagent is designed for use on the COULTER® EPICSTM XLTM/XL-MCtTM or a suitably-equipped-flow-ytometer withra 488 umiaser capableof detecting light scatter (forward and side) and a minimum of four-color fluorescence emission detectable in the following ranges: 504 - 541 nm, 568 - 590 nm, 610 -635 nm, and 660 - 680 nm. Users should refer to the manufacturer's instrument manuals for specific instructions for setting PMT voltages and fluorescence compensation prior to analysis.

Source page: https://510kreport.com/device/K081526
Methodology: https://510kreport.com/methodology