# K082091: Tri T-Stat Reagent Assay (Dried Form) Model 25107-00

- Pathway: 510(k) (Traditional)
- Applicant: Reametrix, Inc.
- Decided: Apr 15, 2009 after 265 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: 4 generations back to K922745 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971205: Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.
- K030408: Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat Tetrachrom CD45-Fitc/CD56-PE/CD19-a, Beckman Coulter, Inc. (2003) Summary page 1.

## Indications for use
The Dry Tri T-STAT (CD3/CD4/CD8) reagent, intended for in vitro diagnostic use, is a three color immunofluorescence stain for the labeling, identification, and enumeration of helper/inducer (CD3+CD4+) and cytotoxic/suppressor (CD3+CD8+) T lymphocytes combined with a precise number of fluorescent counting beads to provide absolute CD4+ and CD8+ T-Cell counts on a single platform. This reagent is intended to be used for flow cytometric analysis of erythrocyte-lysed human whole blood. The Tri T-STAT Reagent can be used to monitor forms of immunodeficiency.

Source page: https://510kreport.com/device/K082091
Methodology: https://510kreport.com/methodology