# K981342: Abbott Cell-Dyn 4000 Immunopit (CD61) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 29, 1998 after 77 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (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. The FDA summary names its predicate without a number.
- (no number) Abbott CELL-DYN® 4000 System: named in the summary without a submission number
- (no number) phase microscopy (for platelet counts < 50 K/uL): named in the summary without a submission number

## Recalls of this device
- Oct 16, 2002 · Not classified · Z-0648-03: Product elicits fluorescent signal interference due to contamination.

## Indications for use
The CELL—DYN® 4000 System with ImmunoPlt (CD61) Assay is a fully automated hematology analyzer, including reporting of the ImmunoPlt (CD61) count, intended for in-vitro diagnostic use in the clinical laboratory of a hospital, medical clinic, or reference laboratory.

Source page: https://510kreport.com/device/K981342
Methodology: https://510kreport.com/methodology