# K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Nov 21, 1997 after 338 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: 1 generation back to K933486 (1994). 1 ancestor in all.
15 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933486: Fascount Systme, Becton Dickinson Immunocytometry Systems (1994) 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
- K071141: BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402 (2007), 2 descendants of its own

## Indications for use
For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and > 650 nm For use with erythrocyte-lysed peripheral whole blood For use with or without an isotype control To characterize and monitor some forms of autoimmune disease To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals

Source page: https://510kreport.com/device/K965053
Methodology: https://510kreport.com/methodology