# K190294: CELL-DYN Emerald 22 AL System

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Mar 15, 2019 after 32 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: 3 generations back to K971152 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110381: Cell-Dyn Emerald 22 System, Abbott Laboratories (2011) Summary page 4.

## Indications for use
The CELL-DYN Emerald 22 AL System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM #, MON %, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood. The CELL-DYN Emerald 22 AL is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

Source page: https://510kreport.com/device/K190294
Methodology: https://510kreport.com/methodology