# K963963: Multiset Software for Automated Flow Cytometric Data Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Dec 12, 1996 after 71 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: 1 generation back to K946055 (1996). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946055: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp, Becton Dickinson Immunocytometry Systems (1996) Summary page 1.

## Most influential descendants
- K974360: Multitest CD3/CD8/CD45/CD4 (1998), 10 descendants of its own
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution (1998), 5 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
- K090967: BD Multitest 6-Color TBNK Reagent, Model 644611 (2009), 2 descendants of its own
- 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

## Recalls of this device
- Sep 6, 2007 · Not classified · Z-0570-2008: Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as d

## Indications for use
MultiSET is an accessory software to in vitro diagnostic reagents employing CD45 gating for identification and enumeration of lymphocyte subsets in human peripheral blood.

Source page: https://510kreport.com/device/K963963
Methodology: https://510kreport.com/methodology