510(k) · Cleared
Recalled · Class III · 2016BD Tritest CD3/CD4/CD45, Model 340383
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 K946055 (Becton Dickinson Immunocytometry Systems, 1996) after a 43-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 6, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946055 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- This deviceK071143 BD Tritest CD3/CD4/CD45, Model 340383Bd Biosciences · 2007
- Descendant · cites it directly · 0 of its ownK081213 BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K081213BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| 0 (this device) | K071143 | BD Tritest CD3/CD4/CD45, Model 340383 | Bd Biosciences | 2007 | — |
| +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 |
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 |
|---|---|---|---|
| * | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpSummary page 2…50 tests. 5.0 Predicate Device The BDTMTritest CD3/CD4/CD45 claims substantial equivalence to the BDTMTritest CD3ICD4/CD45 currently in distribution (FDA 510(k) number K946055/S2) 6.0 Comparison to the Predicate(s) The modifications to the legally marketed device (BDmTritest CD3/CD4/CD45) intends to e… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081213 | BD Facscount CD4 Reagents with Model 339010 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2016 | Class III | Z-2378-2016 | Labeling Change Control | Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP is a three-color direct immunofluorescence reagent for identifying and enumerating percentage of mature human T lymphocytes (CD3+) and T-helper/inducer (CD3+CD4+) cells in erythrocyte-lysed whole blood (LWB).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071143: BD Tritest CD3/CD4/CD45, Model 340383.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071143
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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