# K040026: BD Facs 7-Color Setup Beads

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Sep 10, 2004 after 247 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: 3 generations back to K925274 (1994). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000897: Calibrite Percp-CY5.5 Beads and Facscomp Software, Bd Biosciences (2000) Summary page 1.
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set, Becton Dickinson Immunocytometry Systems (1998) Summary page 1.
- K961623: Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads, Becton Dickinson Monoclonal Center (1996) Summary page 1.
- K925274: Autocomp (TM) Software and Calibrite (TM) Beads, Becton Dickinson Immunocytometry Systems (1994) 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
- Jun 3, 2025 · Class II · Z-2079-2025: Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- Jun 3, 2025 · Class II · Z-2078-2025: Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- Jun 29, 2012 · Class II · Z-2397-2012: Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

## Indications for use
The beads are for use on a BD FACSCantoTM flow cytometer equipped with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation and to monitor daily instrument performance.

Source page: https://510kreport.com/device/K040026
Methodology: https://510kreport.com/methodology