510(k) · Cleared
ClearedCyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · GKZ Counter, Differential Cell
Cleared on Sep 24, 1998 as substantially equivalent to K926124 (Coulter Corp., 1993) after a 97-day review. Its family tree reaches back 1 generation to 1993. 3 of the 18 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Sep 24, 1998
- Review
- 97 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926124 (1993). 16 later devices descend from it, 2 citing it directly. 3 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK926124 Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 MonCoulter Corp. · 1993
- This deviceK982172 Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with…Coulter Corp. · 1998
- Descendant · cites it directly · 14 of its ownK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- Descendant · 4 generations on · 2 of its ownK162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer…Beckman Coulter · 2017
- Descendant · 2 generations on · 2 of its ownK030408 Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody…Beckman Coulter, Inc. · 2003 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · cites it directly14descendants
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 2 generations on6descendants
- K130373Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013 · 3 generations on3descendants
- K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter · 2017 · 4 generations on2descendants
- K030408Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…Beckman Coulter, Inc. · 2003 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926124 | Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 Mon | Coulter Corp. | 1993 | — |
| 0 (this device) | K982172 | Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter… | Coulter Corp. | 1998 | — |
| +1 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| +2 | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | Class I |
| +3 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| +4 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2… | Beckman Coulter | 2017 | — |
| +2 | K030408 | Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent… | Beckman Coulter, Inc. | 2003 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 1 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K926124 | Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 MonSummary page 1…comprised of two monoclonal -+ antibodies of the MsIgG1 subclass conjugated to RD1 and FITC. Couiter Fiea s S Substantial Equivalence: - 510(k) Premarket Notification: K926124 S CYTO-STAT®/COULTER CLONE® CD3(1gG1)-FITC/B4-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MslgG1-FI… | 1993 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 2 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 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.
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?
CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MslgG1-FITC, is used to monitor nonspeécific staining.…
Read the full statement (347 words)
CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MslgG1-FITC, is used to monitor nonspeécific staining.
CYTO-STAT®COULTER CLONE® MsIgG1-RD1/MslgG1-PCS5 Isotypic Control is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® or CYTO-STAT®/COULTER CLONE® Monoclonal Antibody Reagents comprised of two MslgGl subclass monoclonal antibodies conjugated to RD1 and FITC.
CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation.
To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4/T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.
NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells.
As part of a Two Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT®/COULTER® CLONE® CD3(IgG1)-FITC/B4-RD1, CYTO-STAT® CD3-FITC/CD56-RD1 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.
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/K982172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982172: Cyto-Stat CD3-Fitc/CD56-Rdi Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone Msiggi-RD1/Msiggi-Fitc Isotypic Col.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982172
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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