510(k) · Cleared
ClearedBD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402
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, 2007 as substantially equivalent to K965053 (Becton Dickinson Immunocytometry Systems, 1997) after a 43-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 6, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933486 (1994). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK071141 BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model…Bd Biosciences · 2007
- Descendant · cites it directly · 0 of its ownK150815 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto…Becton, Dickinson and Company · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK081213 BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 2008 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402 | Bd Biosciences | 2007 | — |
| +1 | K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb… | Becton, Dickinson and Company | 2015 | 1 |
| +1 | K081213 | BD Facscount CD4 Reagents with Model 339010 | Bd Biosciences | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 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? (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 2…he BDmTritest CD3/CD4/CD45 with Trucount Absolute Count Tubes currently in distribution was originally cleared by CDRH in 1997 under the 510(k) number of K965053. 6.0 Comparison to the Predicate(s) The modifications to the legally marketed device (BDmTritest CD3/CD4/CD45 w… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K150815 (Becton, Dickinson and Company, 2015) has gone furthest, with 0 descendants of its own.
- 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. 2007, 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?
For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 510-545 nm, 562-607 nm, and >650 nm
For use in erythrocyte-lysed whole peripheral blood
For use with or without isotype control
To characterize and monitor some forms of autoimmune disease
To characterize and monitor some forms of immunodeficiency disease, such as in HIV- infected individuals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071141: BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071141
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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