510(k) · Cleared
ClearedMouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) Rpe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dako Corp. · GKZ Counter, Differential Cell
Cleared on Jul 16, 1996 as substantially equivalent to K942797 (Dako Corp., 1994) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jul 16, 1996
- Review
- 75 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942797 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK942797 Monoclonal Mouse Anti-Human T-CellDako Corp. · 1994
- This deviceK961701 Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer)…Dako Corp. · 1996
- Descendant · cites it directly · 0 of its ownK060423 Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and…Dakocytomation California, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060423Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and FluorospheresDakocytomation California, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942797 | Monoclonal Mouse Anti-Human T-Cell | Dako Corp. | 1994 | — |
| 0 (this device) | K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) Rpe | Dako Corp. | 1996 | — |
| +1 | K060423 | Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres | Dakocytomation California, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K942797 | Monoclonal Mouse Anti-Human T-CellSummary page 1…tology and Pathology devices panel, Division of Clinical Laboratory Devices. GKZ DAKQO Monoclonal Mouse Anti-Human T-cell, CD3/FITC, UCHT1 (DAKO Code Number FO818, FDA K942797) and DAKO Monoclonal Mouse Anti-Human helper/inducer T-cell, CD4/RPE, Clone MT310 (DAKO Code Number RO805, FDA K345212) Purifi… | 1994 |
| * | K945212 | Monoclonal Mouse Anti-Human T-Cell, CD4, Clone MT310, Fitc-Conjugated, (Anti-CD4/Fitc… Our OCR of the scanned summary read K345212, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DAKO Monoclonal Mouse Anti-Human helper/inducer T-cell, CD4/RPE…”. | 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 |
|---|---|---|---|
| K060423 | Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres | 2006 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K060423 (Dakocytomation California, Inc., 2006) has gone furthest, with 0 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?
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology. Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow…
Read the full statement (115 words)
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.
Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow cytometry for the analysis of CD3" and CD4" T-cells. This reagent allows simultaneous detection and quantification of CD3"CD4" cells (CD4 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MADb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.
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/K961701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961701: Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) Rpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961701
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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