# K060375: BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166

- Pathway: 510(k) (Traditional)
- Applicant: Bd Biosciences
- Decided: Jun 6, 2006 after 113 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: 4 generations back to K946055 (1996). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution, Becton Dickinson Immunocytometry Systems (1998) Summary page 1.
- K041074: BD Facscanto with BD Facsanto Software, Bd Biosciences (2004) Summary page 1.

## Most influential descendants
- K090967: BD Multitest 6-Color TBNK Reagent, Model 644611 (2009), 2 descendants of its own
- K170974: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (2017), 1 descendant of its own
- K201814: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (2020), 0 descendants of its own

## Indications for use
For use with the BD FACSCanto flow cytometer. For use with whole blood collected in K3 EDTA tubes. For use in the identification and determination of percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K060375
Methodology: https://510kreport.com/methodology