510(k) · Cleared
ClearedCyto-Stat Trichrome CD8-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Msiggi-Fitc/Msiggi-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 Dec 23, 1996 as substantially equivalent to K950742 (Coulter Corp., 1995) after a 69-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 23, 1996
- Review
- 69 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950742 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950742 Cyto-Stat/Coulter Clone CD3-Ecd/T4-RD1/T8-Fitc Monoclonal Antiboey…Coulter Corp. · 1995
- This deviceK964618 Cyto-Stat Trichrome CD8-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Antibody…Coulter Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950742 | Cyto-Stat/Coulter Clone CD3-Ecd/T4-RD1/T8-Fitc Monoclonal Antiboey Reagent | Coulter Corp. | 1995 | — |
| 0 (this device) | K964618 | Cyto-Stat Trichrome CD8-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Antibody Reagent with… | Coulter Corp. | 1996 | — |
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 |
|---|---|---|---|
| * | K950742 | Cyto-Stat/Coulter Clone CD3-Ecd/T4-RD1/T8-Fitc Monoclonal Antiboey ReagentSummary page 1…Goulter Electronics. L Johannesburg. South Afriny Goulter Eigctie Intarts Coults Date: October 11, 1996 Title: Summary of Safety and Effectiveness Information for "K950742 510(k) Additional Information” Product: CYTO-STAT® triCHROME™ CD8-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent with CYTO-STAT… | 1995 |
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.
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™ CD8-FITC/CD4-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+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™…
Read the full statement (143 words)
CYTO-STAT® triCHROME™ CD8-FITC/CD4-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+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ MslgGl-FITC/MsIgG1-RD1/MsIgG1-PCS, is used to monitor nonspecific staining.
CYTO-STAT® triCHROME™ MsIgG1-FITC/MsIgG1-RD1/MslgG1-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™ CDS8-FITC/CD4-RD1/CD3-PC5 Monoclonal Antibody Reagent to identify and enumerate total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ lymphocytes in whole blood by 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/K964618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964618: Cyto-Stat Trichrome CD8-Fitc/CD4-Rdi/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Msiggi-Fitc/Msiggi-RD1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964618
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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