# K970836: Trucount Absolute Count Tubes/Counting Control Beads

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Aug 26, 1997 after 183 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- 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; 3 cite 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

## Recalls of this device
- Jun 24, 2016 · Class II · Z-2252-2016: One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.
- Mar 31, 2016 · Class II · Z-1570-2016: One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patie

## Indications for use
For use with FACS Loader For use with in vitro diagnostic immunophenotyping reagents For use in erythrocyte lysed whole blood For use to obtain absolute counts by flow cytometry

Source page: https://510kreport.com/device/K970836
Methodology: https://510kreport.com/methodology