# K181475: DxH 520 Hematology Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter
- Decided: Mar 1, 2019 after 270 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 K120771 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Beckman Coulter, Inc. (2014) Summary page 6.

## Indications for use
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories and physician's office laboratories. It is used to identify the normal patient with normal system-generated parameters from patients with abnormal parameters and/or flags that require additional studies. The DxH 520 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#, BA%, BA# in whole blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood. The instrument is for use in adult and pediatric populations, including neonates. All numerical results reported for Basophil count and percent values must be reflexed for manual microscopy or followed up for additional testing based on the laboratory’s SOP.

Source page: https://510kreport.com/device/K181475
Methodology: https://510kreport.com/methodology