# K971205: Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Dec 1, 1997 after 244 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.
3 later devices descend from it; 3 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)
- K933486: Fascount Systme, Becton Dickinson Immunocytometry Systems (1994) Summary page 1.

## Most influential descendants
- K101911: Immuknow-the Cylex Immune Cellfunction Assay (2010), 0 descendants of its own
- K082091: Tri T-Stat Reagent Assay (Dried Form) Model 25107-00 (2009), 0 descendants of its own
- K013169: Immune Cell Function Assay (2002), 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: 515-545 nm, 562-607 nm, and >650 nm For use with erythrocyte lysed whole blood For in vitro diagnostic use To identify and enumerate absolute counts of CD3+ and CD3+CD4 and CD3+CD8+ lymphocytes To characterize and monitor some forms of immunodeficiency, such as in HIV infected individuals To characterize and monitor some forms of autoimmune diseases

Source page: https://510kreport.com/device/K971205
Methodology: https://510kreport.com/methodology