# K030408: Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat Tetrachrom CD45-Fitc/CD56-PE/CD19-a

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 4, 2003 after 25 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922745 (1993). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla, Coulter Corp. (1999) Summary page 1.

## Most influential descendants
- K121445: Tetrachrome Reagents and Tetracxp System (2013), 0 descendants of its own
- K082091: Tri T-Stat Reagent Assay (Dried Form) Model 25107-00 (2009), 0 descendants of its own

## Recalls of this device
- May 22, 2012 · Class II · Z-0034-2013: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45
- May 22, 2012 · Class II · Z-0033-2013: The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45
- Sep 16, 2010 · Not classified · Z-1877-2011: A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionalit
- Sep 16, 2010 · Not classified · Z-1876-2011: A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionalit

## Indications for use
CYTO-STAT tetraCHROME CD45-FlTCICD4-PE/CD8-ECD/CD3-PCS Monoclonal antibody reagent is intended “For In Vitro Diagnostic Use”, allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CDI 9-ECDICD3-PC5 Monoclonal antibody reagent is intended “For In Vitro Diagnostic Use”, allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. This reagent can also provide the total lymphocyte percentage.

Source page: https://510kreport.com/device/K030408
Methodology: https://510kreport.com/methodology