# K131301: BD Facs Sample Prep Assistant Iii

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Aug 2, 2013 after 87 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: 1 (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 II system using the BD FACS Sample Prep Assistant III: named in the summary without a submission number

## Recalls of this device
- Jul 8, 2019 · Class II · Z-2358-2020: 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 

## Indications for use
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on RD FACSCantoTM 11 flow cytometry systems: " BD Multitest 6-Color TBNK Reagent with or without BD Trucourit Tubes " BD Multitest IMK Kit with or without BD Trucount Tubes * BD Multitest CD3 FITC/CD I6+CD56 PE/CD45 PerCP/CDI 9 APC with or without RD Trucount Tubes " BD,Multitest CD3 FITC/CDS PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on RD FACSCaliburM flow cytometry systems: " BD Multitest 1MK Kit with or without BD Trucount Tubes " BD Multitest CD3 FITC/CD I6+CD56 PE/CD4S PcrCP/CDI19 APC with or without RD Trucount Tubes " RD Multitest CD3 FITC/C08 PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes * BD Tritest CD3/CD I 6+56/CD45 with or without BD Trucount Tubes * BD Tritest C03/CD I 9/CD45 with or without RD Trucount Tubes * R3D.Tritest CD3/CD4/CD45 with or without BD Trucount Tubes * BD Tritest CD3/CDB/CD45 with or without Trucount Tubes " BD Tritest CD4/CD8/C03 with RD Trucount Tubes For in vitro diagnostic use.

Source page: https://510kreport.com/device/K131301
Methodology: https://510kreport.com/methodology