[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QYO":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":116,"syncDates":117,"translation":124,"marketSummary":131,"recalls":144,"k510s":146,"pmas":153},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":28},7054,"QYO","Hematopoietic Cell Enrichment Kit ","2","866.6120","IM","Immunology","MG","1","A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and\u002For bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection.  It is intended for use with diagnostic assays as part of the pre-analytical workflow.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":23,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":12,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":23,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":18,"fei_number":20,"registration_number":22},[19],"DEN220090",[21],"3004450619",[21],"","N","Ineligible","2026-08-18T05:52:53.878886+00:00","2026-08-24T02:00:47.808424+00:00",0,null,1,[],[33,42,51,60,68,76,84,92,100,108],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},2374,"体外循環用ヘマトクリットモニタ測定セル","Ⅱ","70519000",0.1625,0.210031,0.680619,0.0307765,{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},3565,"細胞・血漿用血液分離装置","Ⅰ","16901000",0.147541,0.196825,0.705982,0.0305789,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},1082,"血液成分分離キット","Ⅲ","58331003",0.12069,0.268293,0.731892,0.029214,{"medical_device_id":61,"generic_name":62,"class_classification":54,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},472,"止血剤注入キット","70397000",0.156863,0.169742,0.670986,0.0288501,{"medical_device_id":69,"generic_name":70,"class_classification":45,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},3538,"ヘマトクリット分析装置","33328000",0.148936,0.153846,0.673889,0.0287785,{"medical_device_id":77,"generic_name":78,"class_classification":45,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},3564,"血球分離装置","15113000",0.117647,0.277612,0.731182,0.028629,{"medical_device_id":85,"generic_name":86,"class_classification":45,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},3557,"ヘマトクリット用遠心機","32429000",0.217391,0.225131,0.615307,0.0163934,{"medical_device_id":93,"generic_name":94,"class_classification":36,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},2749,"歯科用セメントキット","70842000",0.214286,0.190141,0.535193,0.016129,{"medical_device_id":101,"generic_name":102,"class_classification":45,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},3740,"浣腸用キット","11582000",0.189189,0.138182,0.587164,0.015873,{"medical_device_id":109,"generic_name":110,"class_classification":36,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},1868,"骨髄生検キット","16833000",0.0769231,0.196364,0.69431,0.015625,[],{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":125,"definition_ja":126,"commentary_ja":127,"model_name":128,"source_hash":129,"reviewed_by":29,"reviewed_at":29,"created_at":130,"updated_at":130},"造血細胞濃縮キット","造血細胞濃縮キットとは、免疫磁気ビーズを用いた選択法により、血液悪性腫瘍患者から採取されたヒト全血及び／又は骨髄から特定の造血細胞を選択及び濃縮することを目的とするインビトロ診断用医療機器である。本品は、分析前工程の一部として、診断用アッセイと併用することを目的とする。","米国ではクラスIIに分類されており、市販前届出（510(k)）による審査区分の対象となっています。510(k)は、既存の同等品（実質的同等性）との比較に基づいて安全性と有効性を確認する仕組みであり、クラスIII機器に適用される市販前承認（PMA）と比べて簡略化された審査プロセスとなっています。","claude-sonnet-5","2df870a86bb6f7ce14557c9a77323d2f36a58c6bff45ac2cba1ce07202eebcb0","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":142,"model_name":128,"created_at":143,"updated_at":143},"510(k)の累計件数は1件で、参入企業数は1社、直近5年でも1件の届出があり、最新の判定は2023年11月です。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも報告・件数は確認されていません。",{"pma":134,"k510":135,"as_of":137,"events":138,"recalls":139,"top_problems":141},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":30,"latest":136,"applicants":30},"2023-11-06","2026-08",{"death":28,"other":28,"total":28,"injury":28,"last5y":28,"malfunction":28,"latest_month":29},{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":140},[],[],"30bf01f842bdc36dc654804f6c4a15cee415978276301eaf639d076d62405026","2026-08-24T05:22:13.607018+00:00",{"items":145,"total":28},[],{"items":147,"total":30},[148],{"k_number":19,"device_name":149,"applicant":150,"decision_date":136,"clearance_type":151,"decision_code":152,"statement_or_summary":29},"EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)","Stemcell Technologies Canada, Inc.","Direct","DENG",{"items":154,"total":28},[]]