# K961701: Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) Rpe

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Jul 16, 1996 after 75 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
Longest line of descent: 1 generation back to K942797 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942797: Monoclonal Mouse Anti-Human T-Cell, Dako Corp. (1994) Summary page 1.
- K945212: Monoclonal Mouse Anti-Human T-Cell, CD4, Clone MT310, Fitc-Conjugated, (Anti-CD4/Fitc, MT310) Rpe-Conjugated, (Anti-CD4/, Dako Corp. (1996). Our OCR of the scanned summary read K345212, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DAKO Monoclonal Mouse Anti-Human helper/inducer T-cell, CD4/RPE…”.

## 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
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology. Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow cytometry for the analysis of CD3" and CD4" T-cells. This reagent allows simultaneous detection and quantification of CD3"CD4" cells (CD4 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MADb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.

Source page: https://510kreport.com/device/K961701
Methodology: https://510kreport.com/methodology