# K071143: BD Tritest CD3/CD4/CD45, Model 340383

- 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: 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.

## Most influential descendants
- K081213: BD Facscount CD4 Reagents with Model 339010 (2008), 0 descendants of its own

## Recalls of this device
- Jul 18, 2016 · Class III · Z-2378-2016: Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

## Indications for use
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP is a three-color direct immunofluorescence reagent for identifying and enumerating percentage of mature human T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).

Source page: https://510kreport.com/device/K071143
Methodology: https://510kreport.com/methodology