# K110381: Cell-Dyn Emerald 22 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 22, 2011 after 315 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: 2 generations back to K971152 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991605: Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction, Abbott Laboratories (1999) Summary page 1.

## Most influential descendants
- K190294: CELL-DYN Emerald 22 AL System (2019), 0 descendants of its own

## Indications for use
The CELL-DYN Emerald 22 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 K2 EDTA anti-coagulated whole blood. The CELL-DYN Emerald 22 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

Source page: https://510kreport.com/device/K110381
Methodology: https://510kreport.com/methodology