510(k) · Cleared
Recalled · Class II · 2015Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Immunocytometry Systems · GKZ Counter, Differential Cell
Cleared on May 22, 1998 as substantially equivalent to K971110 (Becton Dickinson Immunocytometry Systems, 1997) and 3 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it. It has been recalled once.
- Decided
- May 22, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K946055 (1996). 11 ancestors in all, the oldest K913192 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 2 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 1 generation backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
- This deviceK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998
- Descendant · cites it directly · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
- Descendant · 2 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
- Descendant · cites it directly · 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 · 2 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
- Descendant · cites it directly · 0 of its ownK141932 Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel…Beckman Coulter, Inc. · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · cites it directly3descendants
- K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · 2 generations on2descendants
- K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company · 2017 · cites it directly1descendant
- 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 · 2 generations on0descendants
- K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −2 | K963963 | Multiset Software for Automated Flow Cytometric Data Analysis | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −1 | K974360 | Multitest CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998 | — |
| 0 (this device) | K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution | Becton Dickinson Immunocytometry Systems | 1998 | — |
| +1 | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
| +2 | K090967 | BD Multitest 6-Color TBNK Reagent, Model 644611 | Bd Biosciences | 2009 | 3 |
| +1 | K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical… | Becton, Dickinson and Company | 2017 | 17 |
| +2 | 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 |
| +1 | K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios… | Beckman Coulter, Inc. | 2015 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K971110 | Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount Absolute Count TubesSummary page 1…(21 CFR 807.92(a)(3)) Muld TEST CD3/CD16+56/CD45/CD19, TRUCOUNT absolute count tubes, and Multi TEST IMK Kit are substantially cquivalent‘ to TriTEST CD3/CD16+56/CD45 (K971110), TriTEST CD3/CD19/CD45 (K970742), TRUCOUNT tubes (K970836), and Muld TEST CD3/CD8/CD45/CD4 reagent (974360). Description of the… | 1997 |
| * | K970742 | Tritest CD3 Fitc/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count TubesSummary page 1…CD3/CD16+56/CD45/CD19, TRUCOUNT absolute count tubes, and Multi TEST IMK Kit are substantially cquivalent‘ to TriTEST CD3/CD16+56/CD45 (K971110), TriTEST CD3/CD19/CD45 (K970742), TRUCOUNT tubes (K970836), and Muld TEST CD3/CD8/CD45/CD4 reagent (974360). Description of the Device (21 CFR 807.92(a)(4)) Th… | 1997 |
| * | K970836 | Trucount Absolute Count Tubes/Counting Control BeadsSummary page 1…UCOUNT absolute count tubes, and Multi TEST IMK Kit are substantially cquivalent‘ to TriTEST CD3/CD16+56/CD45 (K971110), TriTEST CD3/CD19/CD45 (K970742), TRUCOUNT tubes (K970836), and Muld TEST CD3/CD8/CD45/CD4 reagent (974360). Description of the Device (21 CFR 807.92(a)(4)) The Becton Dickinson CD3 flu… | 1997 |
| * | K974360 | Multitest CD3/CD8/CD45/CD4 Cleared while this submission was under review Summary page 1…t are substantially cquivalent‘ to TriTEST CD3/CD16+56/CD45 (K971110), TriTEST CD3/CD19/CD45 (K970742), TRUCOUNT tubes (K970836), and Muld TEST CD3/CD8/CD45/CD4 reagent (974360). Description of the Device (21 CFR 807.92(a)(4)) The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD16+56 phycoeryth… | 1998 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | 2006 | 3 |
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD… | 2017 | 1 |
| K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2015 | Class II | Z-1370-2015 | Mixed-up of materials/components | The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K060375 (Bd Biosciences, 2006) has gone furthest, with 3 descendants of its own.
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?
MultiTEST CD3/CD16+56/CD45/CD19 and Multi TEST IMK kit For use with Becton Dickinson FAC® flow cytometers equipped with a blue (488-nm) and red diode (635-nm) laser. Monoclonal antibody reagents for identification and enumeration of mature human lymphocyte subsets in peripheral blood of normal individuals and patients with certain immune dysfunction. Muld TEST CD3/CD16+56/CD45/CD19 provides percentages and absolute counts of T (CD3*), NK(CD3CD16*CD56%)…
Read the full statement (124 words)
MultiTEST CD3/CD16+56/CD45/CD19 and Multi TEST IMK kit
For use with Becton Dickinson FAC® flow cytometers equipped with a blue (488-nm) and red diode (635-nm) laser.
Monoclonal antibody reagents for identification and enumeration of mature human lymphocyte subsets in peripheral blood of normal individuals and patients with certain immune dysfunction.
Muld TEST CD3/CD16+56/CD45/CD19 provides percentages and absolute counts of T (CD3*), NK(CD3CD16*CD56%), and B (CD3'CD19*) lymphocytes.
MultiTEST CD3/CD8/CD45/CD4 provides percentages and absolute counts of T (CD3"), helper/inducer T (CD3'CD4') and suppressor/cytotoxic T (CD3'CD8") lymphocytes.
For use with erythrocyte lysed whole blood without an isotype control.
To characterize and monitor forms of auto immune diseases, such as lupus.
To characterize and monitor congenital or acquired immunodeficiences, such as SCID or AIDS.
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/K980858 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980858
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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