510(k) · Cleared
ClearedCyto-Stat Trichrome CD45-Fitc/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome CD45-Fitc/MSIGG1-RD1
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 Nov 9, 1998 as substantially equivalent to K926124 (Coulter Corp., 1993) after a 143-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 9, 1998
- Review
- 143 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926124 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926124 Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 MonCoulter Corp. · 1993
- This deviceK982167 Cyto-Stat Trichrome CD45-Fitc/CD19-RD1/CD3-PC5 Monoclonal Antibody…Coulter Corp. · 1998
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) | K982167 | Cyto-Stat Trichrome CD45-Fitc/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent… | Coulter Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | K926124 | Cyto-Stat/Coulter Clone CD3 (IGG1)-Fitc/B4-RD1 MonSummary page 1…agents comprised of CD45-FITC and two monoclonal ~ antibodies of the MsIgG1 subclass conjugated to RD1 and PC5. Substantial Equivalence: 510(k) Premarket Notification: K926124 CYTO-STAT®/COULTER CLONE® CD3(IgG1)-FITC/B4-RD1 Monoclonal Antibody Reagent with CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MslgG1-FITC… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K926124.
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® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsigG1-RD1/MsIgG1-PC5, is used to monitor…
Read the full statement (333 words)
CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsigG1-RD1/MsIgG1-PC5, is used to monitor nonspecific staining.
CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three 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® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5.
CD3+ and/or CD19+ 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+ and/or CD19+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ and/or CD19+ 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+ and/or CD19+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T and/or B lymphocyte quantitation may be useful as an aid in monitoring these cellular populations.
As part of a Three Color Lymphocyte Inmunophenotyping Panel which includes the NK (Natural Killer) lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RIDD1/CD3-PC5 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/K982167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982167: Cyto-Stat Trichrome CD45-Fitc/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome CD45-Fitc/MSIGG1-RD1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982167
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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