# K970326: Tritest Reagent CD3 Fitc/CD8 PE/CD45 Percp;with Trucount Absolute Count Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Nov 21, 1997 after 297 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 K913192 (1992). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913192: Simultest (TM) Imk-Lymphocyte, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.
- 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
- K170974: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (2017), 1 descendant 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 use with or without an isotype control To characterize and monitor forms of autoimmune diseases, such as lupus To characterize and monitor congenital or acquired immunodeficiencies, such as SCID or AIDS

Source page: https://510kreport.com/device/K970326
Methodology: https://510kreport.com/methodology