# K050191: Modification to BD Facscanto System with BD Facscanto Clinical Software

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 22, 2005 after 26 days
- Product code: PER (Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis)
- Device class: 1
- Regulation: 21 CFR 862.2750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD FACSCanto system with BD FACSCanto clinical software using manual pipetting: named in the summary without a submission number

## Recalls of this device
- Jul 8, 2019 · Class II · Z-2356-2020: The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instr
- Jul 8, 2019 · Class II · Z-2357-2020: The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the 
- Feb 19, 2010 · Not classified · Z-1940-2010: Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe
- Oct 2, 2007 · Not classified · Z-0526-2008: Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.

## Indications for use
Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method. Immunophenotyping of lymphocyte subsets including CD3+CD8 +, CWD3CD4 4 , CD3-CD 16+and/or CD56 +, CD3YCD19 +, and CD3 +. For in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant II.

Source page: https://510kreport.com/device/K050191
Methodology: https://510kreport.com/methodology