# K010953: Cell-Dyn 4000 Immuno T-Cell (CD3/4/8) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 6, 2001 after 68 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 16, 2005 · Not classified · Z-0527-06: T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
- Oct 16, 2002 · Not classified · Z-0648-03: Product elicits fluorescent signal interference due to contamination.

Source page: https://510kreport.com/device/K010953
Methodology: https://510kreport.com/methodology