{"entity":{"id":"haematology-analysers","kind":"technology","name":"Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio)","aka":["Full blood count analyser","Complete blood count analyser","Haematology analyser","Sysmex XN","UniCel DxH 900","CellaVision","Scopio X100","Digital morphology"],"tldr":"The machines that count blood cells for the full blood count checked before every chemotherapy cycle, and cameras with software that find and sort cells on a blood or bone marrow slide for a specialist to review.","summary":"Automated cell counters are FDA product code GKZ. Sysmex's XN-Series analysers (K141681, 5 December 2014) enumerate red and white cells, platelets and immature granulocytes in whole blood and cells in body fluids; the smaller XN-L followed (K182389, 25 January 2019), and Beckman Coulter's UniCel DxH 900 (K240252, 5 July 2024). Digital morphology systems locate and pre-classify cells on stained slides for a trained operator to confirm: CellaVision DC-1 (K200595, 16 October 2020), Scopio Labs' X100 for peripheral blood (K201301, 2 October 2020) and SigTuple's AI100 (K221309, 19 September 2023). Scopio's X100 with full field bone marrow aspirate application received De Novo classification on 22 March 2024 (DEN230034), creating product code SAL; it \"assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation\", with every classification reviewed by a qualified operator.","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K141681: Sysmex XN-Series (5 December 2014)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141681"},{"label":"FDA 510(k) K182389: Sysmex XN-L (25 January 2019)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182389"},{"label":"FDA 510(k) K240252: UniCel DxH 900 (5 July 2024)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240252"},{"label":"FDA 510(k) K200595: CellaVision DC-1 (16 October 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200595"},{"label":"FDA 510(k) K201301: Scopio X100 peripheral blood smear (2 October 2020)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201301"},{"label":"FDA 510(k) K221309: SigTuple AI100 with Shonit (19 September 2023)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221309"},{"label":"FDA De Novo DEN230034: Scopio X100 with full field bone marrow aspirate application","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230034"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["aml","cll","mds","multiple-myeloma"],"sections":["diagnostics","devices"],"technologies":["flow-cytometers","digital-pathology-ai","bone-marrow-biopsy-devices","tumour-marker-immunoassay-analysers","digital-pcr-platforms"],"targets":[],"drugs":[],"companies":["beckman-coulter"],"institutions":[],"pathways":[],"terms":["cytopenias"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"Impedance, fluorescence flow cytometry and light scatter count and classify cells in a diluted blood sample; digital morphology systems scan a stained slide, image each cell and use classifiers to propose a cell type.","strengths":["Fast blood counts that decide whether chemotherapy can go ahead","Digital slides allow remote review"],"limitations":["Flags still need a person to review the slide","Pre-classification can be wrong for abnormal cells"],"since":2014},"route":"/technologies/haematology-analysers/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"tumour-marker-immunoassay-analysers","kind":"technology","name":"Automated analysers for tumour-marker blood tests (Elecsys, Atellica, Access, VITROS, Lumipulse)","route":"/technologies/tumour-marker-immunoassay-analysers/"},{"id":"digital-pathology-ai","kind":"technology","name":"Digital pathology & AI","route":"/technologies/digital-pathology-ai/"},{"id":"digital-pcr-platforms","kind":"technology","name":"Digital PCR and BCR::ABL1 monitoring kits (QXDx, Fastplex, Xpert BCR-ABL Ultra)","route":"/technologies/digital-pcr-platforms/"},{"id":"flow-cytometers","kind":"technology","name":"Flow cytometers","route":"/technologies/flow-cytometers/"},{"id":"m-protein-laboratory-analysers","kind":"technology","name":"M-protein analysers: mass spectrometry, capillary electrophoresis and free light chain assays (EXENT, Capillarys, Freelite)","route":"/technologies/m-protein-laboratory-analysers/"},{"id":"bone-marrow-biopsy-devices","kind":"technology","name":"Powered bone marrow biopsy drivers (OnControl, BD Trek, OmniBone)","route":"/technologies/bone-marrow-biopsy-devices/"}],"company":[{"id":"beckman-coulter","kind":"company","name":"Beckman Coulter","route":"/companies/beckman-coulter/"}],"term":[{"id":"cytopenias","kind":"term","name":"Cytopenias and myelosuppression","route":"/terms/cytopenias/"}]}}