# K102064: BD Facs Sample Prep Assistant Iii (Spa Iii)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 7, 2011 after 227 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
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 FACS Sample Prep Assistant II (SPA II): named in the summary without a submission number

## Indications for use
Pipetting blood, reagents and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems: * BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes * BD Multitest IMK Kit with or without BD Trucount Tubes * BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or without BD Trucount Tubes * BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes For in vitro diagnostic use.

Source page: https://510kreport.com/device/K102064
Methodology: https://510kreport.com/methodology