510(k) · Cleared
ClearedIQ Products Triple-Color Flow Cytometry Reagents, IQ Products CD45-Fitc/CD4-PE/CD3-Cyq, IQ Products CD45-Fitc/CD8-PE/CDQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iq Corp. · GKZ Counter, Differential Cell
Cleared on Sep 11, 2002 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 11, 2002
- Review
- 42 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgGl R-PE/ IgGl CyQ may be used. IQ Prep Reagent CD45 FITCI CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to…
Read the full statement (246 words)
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgGl R-PE/ IgGl CyQ may be used.
IQ Prep Reagent CD45 FITCI CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, total CD3+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ lgGl R-PE/ lgGl CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive/CD4 positive lyniphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgGl R-PE/ IgGl CyQ is used.
IQ Prep Reagent CD45 FITC/IgGl R-PE/IgGI CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents. These reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgGl subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022528 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022528: IQ Products Triple-Color Flow Cytometry Reagents, IQ Products CD45-Fitc/CD4-PE/CD3-Cyq, IQ Products CD45-Fitc/CD8-PE/CDQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022528
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026