# K090810: Thermo Scientific Cyto-Cal Count Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Sep 18, 2009 after 177 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: 2 generations back to K933486 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.

## Indications for use
Thermo Scientific Cyto-CalTM Count Tubes are used for determining absolute counts of leucocytes in blood. Thermo Scientific Cyto-CaI TM Count Tubes are used with the immnuphenotyping reagents BD TriTEST TM , flow cytometers BD FACS Calibur or BD FACS Canto, and software BD CellQuest or DIVA. Thermo Scientific Cyto-CalTM Count Tubes can be used with the BD FACSTM Loader. This in vitro diagnostic device is intended for clinical use only.

Source page: https://510kreport.com/device/K090810
Methodology: https://510kreport.com/methodology