# K022528: IQ Products Triple-Color Flow Cytometry Reagents, IQ Products CD45-Fitc/CD4-PE/CD3-Cyq, IQ Products CD45-Fitc/CD8-PE/CDQ

- Pathway: 510(k) (Traditional)
- Applicant: Iq Corp.
- Decided: Sep 11, 2002 after 42 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K022528
Methodology: https://510kreport.com/methodology