510(k) · Cleared
ClearedBD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Biosciences · GKZ Counter, Differential Cell
Cleared on Jun 6, 2006 as substantially equivalent to K980858 (Becton Dickinson Immunocytometry Systems, 1998) and 1 other predicate after a 113-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Jun 6, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K946055 (1996). 16 ancestors in all, the oldest K913192 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 3 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 2 generations backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
- 1 generation backK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
- This deviceK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
- Descendant · cites it directly · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5…Becton, Dickinson and Company · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · cites it directly2descendants
- K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company · 2017 · 2 generations on1descendant
- K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −3 | K963963 | Multiset Software for Automated Flow Cytometric Data Analysis | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −2 | K974360 | Multitest CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998 | — |
| −1 | K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution | Becton Dickinson Immunocytometry Systems | 1998 | 1 |
| 0 (this device) | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
| +1 | K090967 | BD Multitest 6-Color TBNK Reagent, Model 644611 | Bd Biosciences | 2009 | 3 |
| +2 | K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical… | Becton, Dickinson and Company | 2017 | 17 |
| +3 | K201814 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical… | Becton, Dickinson and Company | 2020 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionSummary page 1…GKZ Substantially Equivalent Predicate Device BD Multitest 6-color TBNK reagent with BD Trucount tubes is substantially equivalent to BD Multitest IMK kit (K980858) when used with the BD FACSCanto system with BD FACSCanto clinical software (K041074). BD Biosciences 510(k) Notification… | 1998 |
| * | K041074 | BD Facscanto with BD Facsanto SoftwareSummary page 1…reagent with BD Trucount tubes is substantially equivalent to BD Multitest IMK kit (K980858) when used with the BD FACSCanto system with BD FACSCanto clinical software (K041074). BD Biosciences 510(k) Notification Page I of 9 BD Multitest 6-Color TBNK Reagent w… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090967 | BD Multitest 6-Color TBNK Reagent, Model 644611 | 2009 | 2 |
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 10 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 16 ancestors have a recall of any class.
- Of its descendants, K090967 (Bd Biosciences, 2009) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K980858.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For use with the BD FACSCanto flow cytometer.
For use with whole blood collected in K3 EDTA tubes.
For use in the identification and determination of percentages and absolute counts of T, B, and natural killer (NK) cells as well as the CD4 and CD8 subpopulations of T cells in peripheral blood.
For in vitro diagnostic use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060375: BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060375
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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