# K964856: CD3 Fitc/CD19 R-PE/CD45 Tri-Color Monoclonal Antibody Combination

- Pathway: 510(k) (Traditional)
- Applicant: Caltag Laboratories, Inc.
- Decided: Jan 17, 1997 after 44 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. The FDA summary names its predicate without a number.
- (no number) Caltag CD3 FITC single monoclonal antibody for in vitro diagnostic use: named in the summary without a submission number
- (no number) Caltag CD19 R-PE single monoclonal antibody for in vitro diagnostic use: named in the summary without a submission number
- (no number) Coulter CD19 RD1 single monoclonal antibody for in vitro diagnostic use: named in the summary without a submission number

## Indications for use
CALTAG CD3/CD19/CDA4S5 is a fluorescent reagent containing a combination of CD3, CD19 and CD45 monoclonal antibodies conjugated to fluorescein, phycoerythrin and the tandem fluorochrome PE-CyS5, respectively. This reagent ‘permits the simiiltanegas identification:of CD3 + mature T Iynmphocytes, CR19+ ° ‘mature B-lymphocytes, and CD45+ leukocymanciudmg lymphocytes, monocytcs and granulocytes, by flow cytometric methods. '

Source page: https://510kreport.com/device/K964856
Methodology: https://510kreport.com/methodology