# K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: May 22, 1998 after 78 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: 3 generations back to K946055 (1996). 11 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971110: Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.
- K970742: Tritest CD3 Fitc/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.
- K970836: Trucount Absolute Count Tubes/Counting Control Beads, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.
- K974360: Multitest CD3/CD8/CD45/CD4, Becton Dickinson Immunocytometry Systems (1998). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K141932: Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios (2015), 0 descendants of its own

## Recalls of this device
- Mar 6, 2015 · Class II · Z-1370-2015: The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.

## Indications for use
MultiTEST CD3/CD16+56/CD45/CD19 and Multi TEST IMK kit For use with Becton Dickinson FAC® flow cytometers equipped with a blue (488-nm) and red diode (635-nm) laser. Monoclonal antibody reagents for identification and enumeration of mature human lymphocyte subsets in peripheral blood of normal individuals and patients with certain immune dysfunction. Muld TEST CD3/CD16+56/CD45/CD19 provides percentages and absolute counts of T (CD3*), NK(CD3CD16*CD56%), and B (CD3'CD19*) lymphocytes. MultiTEST CD3/CD8/CD45/CD4 provides percentages and absolute counts of T (CD3"), helper/inducer T (CD3'CD4') and suppressor/cytotoxic T (CD3'CD8") lymphocytes. For use with erythrocyte lysed whole blood without an isotype control. To characterize and monitor forms of auto immune diseases, such as lupus. To characterize and monitor congenital or acquired immunodeficiences, such as SCID or AIDS. For in vitro diagnostic use

Source page: https://510kreport.com/device/K980858
Methodology: https://510kreport.com/methodology