510(k) · Cleared
ClearedThermo Scientific Cyto-Cal Count Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · GKZ Counter, Differential Cell
Cleared on Sep 18, 2009 as substantially equivalent to K965053 (Becton Dickinson Immunocytometry Systems, 1997) after a 177-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Sep 18, 2009
- Review
- 177 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933486 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK933486 Fascount SystmeBecton Dickinson Immunocytometry Systems · 1994 · Recalled
- 1 generation backK965053 Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count…Becton Dickinson Immunocytometry Systems · 1997
- This deviceK090810 Thermo Scientific Cyto-Cal Count TubesMicrogenics Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933486 | Fascount Systme | Becton Dickinson Immunocytometry Systems | 1994 | 1 |
| −1 | K965053 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes | Becton Dickinson Immunocytometry Systems | 1997 | — |
| 0 (this device) | K090810 | Thermo Scientific Cyto-Cal Count Tubes | Microgenics Corp. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K965053 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count TubesSummary page 1…use only. SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE Thermo Scientific Cyto-Ca IT M Count Tubes are substantially equivalent to the previously cleared BD Trucount Tubes (K965053) DESCRIPTION OF DEVICE Thermo Scientific Cyto-CaI TM Count Tubes contain uniform 5.4 pm microspheres encapsulated with three. d… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K965053.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090810 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090810: Thermo Scientific Cyto-Cal Count Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090810
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026