# K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Feb 17, 1998 after 155 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925274 (1994). 2 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961623: Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads, Becton Dickinson Monoclonal Center (1996) Summary page 1.

## Most influential descendants
- K041074: BD Facscanto with BD Facsanto Software (2004), 6 descendants of its own
- K040725: BD Facscanto System (2004), 4 descendants of its own
- K060375: BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 (2006), 3 descendants of its own
- K141468: BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (2015), 2 descendants of its own
- K090967: BD Multitest 6-Color TBNK Reagent, Model 644611 (2009), 2 descendants of its own

## Recalls of this device
- Jun 15, 2015 · Class III · Z-2090-2015: Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and I

## Indications for use
For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur). An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping. For adjusting instrument settings: aligning the signal from the bluc and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time. For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals. For monitoring the sensitivity of che side scateer (SSC) and fluorescence (FL1, FL2, FL3, and FL4) dctecrors and verifying adequate separation of system noise from forward scatter (FSC) signals. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K973483
Methodology: https://510kreport.com/methodology