# K071141: BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402

- Pathway: 510(k) (Special)
- Applicant: Bd Biosciences
- Decided: Jun 6, 2007 after 43 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 K933486 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 2.

## Most influential descendants
- K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (2015), 0 descendants of its own
- K081213: BD Facscount CD4 Reagents with Model 339010 (2008), 0 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: 510-545 nm, 562-607 nm, and >650 nm For use in erythrocyte-lysed whole peripheral blood For use with or without 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/K071141
Methodology: https://510kreport.com/methodology