# K974360: Multitest CD3/CD8/CD45/CD4

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Mar 11, 1998 after 112 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
Longest line of descent: 2 generations back to K946055 (1996). 7 ancestors in all.
10 later devices descend from it; 7 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970326: Tritest Reagent CD3 Fitc/CD8 PE/CD45 Percp;with Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997). Cleared while this submission was under review Summary page 1.
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997). Cleared while this submission was under review Summary page 1.
- K970836: Trucount Absolute Count Tubes/Counting Control Beads, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.
- K963963: Multiset Software for Automated Flow Cytometric Data Analysis, Becton Dickinson Immunocytometry Systems (1996) Summary page 1.

## Most influential descendants
- 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
- K201814: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (2020), 0 descendants of its own

## Indications for use
For the FACS® family of flow cytometers equipped with a blue (488-nm) and a red diode (635-nm) laser. A monoclonal antibody reagent for identification and enumeration of matur¢ human T lymphocyte subsets in human peripheral blood. For use with erythrocyte lysed whole blood. To characterize and monitor forms of autoimmune diseases, such as lupus. To characterize and monito or acquired immunodeficiencics, such as SCID or AIDS. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K974360
Methodology: https://510kreport.com/methodology