510(k) · Cleared
Recalled · Class III · 2015BD Facscount CD4 Reagents with Model 339010
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 Aug 14, 2008 as substantially equivalent to K071143 (Bd Biosciences, 2007) and 1 other predicate after a 106-day review. Its family tree reaches back 3 generations to 1994. It has been recalled 2 times.
- Decided
- Aug 14, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933486 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK933486 Fascount SystmeBecton Dickinson Immunocytometry Systems · 1994 · Recalled
- 2 generations backK965053 Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count…Becton Dickinson Immunocytometry Systems · 1997
- 1 generation backK071141 BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model…Bd Biosciences · 2007
- This deviceK081213 BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933486 | Fascount Systme | Becton Dickinson Immunocytometry Systems | 1994 | 1 |
| −2 | K965053 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes | Becton Dickinson Immunocytometry Systems | 1997 | — |
| −1 | K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402 | Bd Biosciences | 2007 | — |
| 0 (this device) | K081213 | BD Facscount CD4 Reagents with Model 339010 | Bd Biosciences | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K071143 | BD Tritest CD3/CD4/CD45, Model 340383Summary page 1…solution 5.0: Predicate Device: BD FACSCount CD4 Reagents is substantially equivalent to BD Tritest CD3/CD4/CD45 with and without BD Trucount absolute count tubes (K071143 and K071141) for the enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lympho… | 2007 |
| * | K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Summary page 1…n 5.0: Predicate Device: BD FACSCount CD4 Reagents is substantially equivalent to BD Tritest CD3/CD4/CD45 with and without BD Trucount absolute count tubes (K071143 and K071141) for the enumerating the absolute counts of CD4 T lymphocytes and the percentage of lymphocytes that are CD4 T lymphocytes in unl… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2015 | Class III | Z-2090-2015 | Labeling Change Control | Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50). |
| Jan 29, 2009 | Not classified | Z-1007-2010 | Package design/selection | The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 FACSCount CD4 reagents are used to enumerate the absolute counts of CD4 T lymphocytes and determine the percentage of lymphocytes that are CD4 T lymphocytes in unlysed whole blood (CD4 count and CD4 percentage). The reagents are for in vitro diagnostic use on a BD FACSCount instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081213: BD Facscount CD4 Reagents with Model 339010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081213
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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