# K030513: Cell-Dyn 1800 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 12, 2003 after 82 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K870233 (1987). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K870233: Cell-Dyn 1600 Multiparameter Auto. Hema. Analyzer, Abbott Diagnostics (1987) Summary page 1.

## Most influential descendants
- K111534: Abacus 3CP (2012), 0 descendants of its own
- K081495: Cell-Dyn Emerald System (2009), 0 descendants of its own

## Recalls of this device
- Nov 30, 2009 · Not classified · Z-1698-2011: The use of the device assemblies has been extended to a 6 month useful life.
- Jun 8, 2009 · Not classified · Z-1630-2010: Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
- Oct 27, 2006 · Not classified · Z-0455-2008: Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degree

## Indications for use
The CELL-DYN 1800 System is an automated, multiparameter hematology analyzer designed to report sixteen parameters relating to the cells of EDTA-anticoagulated blood.

Source page: https://510kreport.com/device/K030513
Methodology: https://510kreport.com/methodology