# K992875: Sysmex XE-2100, Automatated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Nov 9, 1999 after 75 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912494 (1991). 4 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964375: Sysmex SE/Ram-1, Sysmex Corp. (1997) Summary page 3.
- K950508: Sysmex SF-3000, Sysmex Corp. (1995) Summary page 3.

## Most influential descendants
- K061616: Coulter LH 780 Hematology Analyzer (2006), 1 descendant of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K160429: BC-5390 Auto Hematology Analyzer (2016), 0 descendants of its own
- K151133: Pentra XLR (2015), 0 descendants of its own
- K081930: Unicel DXH 800 Coulter Cellular Analysis System (2008), 0 descendants of its own

## Recalls of this device
- Jun 1, 2012 · Class II · Z-0254-2013: There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lo

## Indications for use
The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in EDTA anti-coagulated blood. WBC White Blood Cells or leukocyte count Neut% Neutrophil percent Neut# Neutrophil absolute count Lymph% Lymphocyte percent Lymph# Lymphocyte absolute count Mono% Monocyte percent Mono# Monocyte absolute count Eo% Eosinophil percent Eo# Eosinophil absolute count Baso% Basophil percent Baso# Basophil absolute count NRBC% Nucleated red blood cell percent NRBCH# Nucleated red blood cell absolute count RBC Red Blood Cell or erythrocyte count HGB Hemoglobin concentration HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Cell Hemoglobin MCHC Mean Cell Hemoglobin Concentration RDW-CV Red Cell Distribution Width-Coefficient of Variation RDW-SD Red Cell Distribution Width-Standard Deviation RET% Reticulocyte percent RET# Reticulocyte absolute count IRF Immature Reticulocyte Fraction HFR* High Fluorescent Ratio MFR* Medium Fluorescent Ratio LFR* Low Fluorescent Ratio PLT Platelet count MPV Mean Platelet Volume PDW* Platelet Distribution Width P-LCR* Platelet- Large Cell Ratio PCT* Plateletcrit *Not reportable in the USA

Source page: https://510kreport.com/device/K992875
Methodology: https://510kreport.com/methodology