# K160429: BC-5390 Auto Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 1, 2016 after 198 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 K912494 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer, Sysmex Corp. (1999) Summary page 4.

## Indications for use
The BC-5390 Auto Hematology Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in clinical laboratories. The BC-5390 Auto Hematology Analyzer provides complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV) and leukocyte 5-Part differential ((Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%) for whole blood specimens collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)] obtained from venous or capillary blood collection. The purpose of the BC-5390 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.

Source page: https://510kreport.com/device/K160429
Methodology: https://510kreport.com/methodology