# K090967: BD Multitest 6-Color TBNK Reagent, Model 644611

- Pathway: 510(k) (Traditional)
- Applicant: Bd Biosciences
- Decided: Jul 31, 2009 after 116 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K946055 (1996). 17 ancestors in all.
2 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)
- K060375: BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166, Bd Biosciences (2006) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Oct 3, 2022 · Class II · Z-0172-2023: Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root ca
- Oct 3, 2022 · Class II · Z-0173-2023: Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.
- Oct 3, 2022 · Class II · Z-0171-2023: Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root ca

## Indications for use
BD Multitest 6-color TBNK reagent with optional BD Trucount tubes is a six-color direct immunofluorescence reagent for use with BD FACSCanto and BD FACSCanto II flow cytometers to identify and determine the 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. BD Multitest 6-color TBNK reagent and BD Trucount tubes can be used with the BD FACS Loader.

Source page: https://510kreport.com/device/K090967
Methodology: https://510kreport.com/methodology