# K964974: Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/Rpe

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Jun 24, 1997 after 194 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Simultest LeucoGATE: named in the summary without a submission number

## Most influential descendants
- K060423: Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres (2006), 0 descendants of its own

## Indications for use
Monoclonal Mouse Anti-Human Leukocyte Common Antigen, CD45, FITC-Conjugated, Clone T29/33 (Anti-CD45/FITC, T29/33) and Monoclonal Mouse Anti-Human Monocyte, CD 14, RPE-Conjugated, Clone TUK4 (Anti-CD14/RPE. TUK4) have been developed for use in flow cytometry. This reagent may be used to optimize the gating of lymphocytes when analyzing peripheral whole blood or peripheral blood mononuclear cell preparations. This reagent is one component of the suggested monoclonal antibody (MAb) combination for routine immunophenotyping of lymphocytes in peripheral blood. Lymphocyte gating is assigned by selection of the upper and lower channel numbers to define the lymphocyte population and is a quality control function for flow cytometry. Gating verification is performed by identification of 99%1% of the cells as CD45"™* with CD14" as 2% or less of the cell population. Note that this definition of “lymphocyte” does not give complete and unambiguous resolution from ail other cell types. When optimizing light scatter gates for lymphocytes, operator and/or software algorithms are minimizing the number of lymphocytes excluded while still maintaining acceptable levels of contaminating cell types. Lymphocyte gate purity may be calculated by determining the percentage of non-lymphocyte events within the gate. Most non-lymphocytes are CD14 positive. Because each flow cytometer has different operating characteristics, each laboratory must determine its optimal operating procedure.

Source page: https://510kreport.com/device/K964974
Methodology: https://510kreport.com/methodology