# K970742: Tritest CD3 Fitc/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Oct 22, 1997 after 236 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.
6 later devices descend from it; 1 cites it directly.
0 of 9 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.
- K950342: Tritest Reagent CD3 Fitc/CD19 PE/CD45 Percp, Becton Dickinson Immunocytometry Systems (1996) Summary page 1.

## Most influential descendants
- 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
- K201814: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (2020), 0 descendants of its own

## Indications for use
For use with any flow cytometer with specified detection ranges For use with erythrocyte lysed whole blood For use with or without an isotype control For in vitro diagnostic use To identify and enumerate percentages and absolute counts of CD3+ and CD19+ lymphocytes To characterize and monitor some forms of immunodeficiency To characterize and monitor some forms of autoimmune diseases

Source page: https://510kreport.com/device/K970742
Methodology: https://510kreport.com/methodology