[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QQT":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":113,"syncDates":114,"translation":121,"marketSummary":128,"recalls":143,"k510s":145,"pmas":147},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":28,"pma_count":30,"event_count":28},3492,"QQT","Immunohistochemistry Assay, Antibody, Ki-67","3","","Unknown","PA","2","The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens.  The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":11,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":24,"medical_specialty_description":10,"summary_malfunction_reporting":25},{"fei_number":17,"pma_number":21,"registration_number":23},[18,19,20],"2022180","2916205","3009189893",[22],"P210026",[18,19,20],"N","Ineligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:47.949024+00:00",0,null,3,[],[33,42,50,58,65,73,81,89,97,105],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},3555,"ラジオイムノアッセイ用装置","Ⅰ","35506000",0.178571,0.225201,0.685105,0.031545,{"medical_device_id":43,"generic_name":44,"class_classification":36,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},3505,"酵素免疫測定装置","35706010",0.214286,0.155932,0.668545,0.031498,{"medical_device_id":51,"generic_name":52,"class_classification":36,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},3512,"免疫発光測定装置","36223010",0.238095,0.215434,0.656463,0.0313188,{"medical_device_id":59,"generic_name":60,"class_classification":36,"jmdn_code":61,"name_similarity":46,"definition_similarity":62,"vector_similarity":63,"score":64},3513,"移動式免疫発光測定装置","36223020",0.223684,0.656912,0.0312805,{"medical_device_id":66,"generic_name":67,"class_classification":36,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},3506,"移動式酵素免疫測定装置","35706020",0.190476,0.163194,0.663935,0.0307692,{"medical_device_id":74,"generic_name":75,"class_classification":36,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.174603,0.183486,0.652166,0.0296313,{"medical_device_id":82,"generic_name":83,"class_classification":36,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},3510,"免疫蛍光分析装置","35707010",0.135593,0.159159,0.676388,0.0292869,{"medical_device_id":90,"generic_name":91,"class_classification":36,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":96},3514,"粒子計測免疫測定装置","70181000",0.19697,0.146718,0.633057,0.0289583,{"medical_device_id":98,"generic_name":99,"class_classification":36,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},3511,"移動式免疫蛍光分析装置","35707020",0.121212,0.165138,0.67114,0.0282187,{"medical_device_id":106,"generic_name":107,"class_classification":36,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},3567,"イムノアッセイ用検体前処理装置","30870000",0.169492,0.173077,0.635596,0.0281746,[],{"510k":115,"classification":116,"enforcement":117,"event":118,"pma":119,"warning_letter":120},"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":122,"definition_ja":123,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":29,"reviewed_at":29,"created_at":127,"updated_at":127},"Ki-67免疫組織化学検査用抗体","Ki-67抗体は、ヒト臨床組織検体におけるKi-67タンパク質発現を同定することを目的とした定性的免疫組織化学抗体である。KI-67抗体は、特定のFDA承認治療薬による治療対象となる患者を特定する際の補助として用いることが適応とされている。","本品は米国においてクラスIIIに分類されており、市販に際してはPMA（市販前承認）による厳格な審査が求められます。クラスIIIは通常、人体へのリスクが高い、または有効性・安全性を裏付ける十分な情報がない機器に適用される区分であり、コンパニオン診断薬としての位置づけを反映して市販前承認が必要とされていると考えられます。","claude-sonnet-5","04351723cfa9d54426a584b547aa286eabab1b2812fac2ba6e90839d9926b7fe","2026-08-24T03:31:52.244646+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":141,"model_name":125,"created_at":142,"updated_at":142},"本製品はPMA（市販前承認）区分の機器で、本承認が1件、一部変更承認が2件承認されており、直近の判定は2025年2月です。不具合報告および回収については、いずれも累計件数が確認されていません。",{"pma":131,"k510":135,"as_of":136,"events":137,"recalls":138,"top_problems":140},{"latest":132,"originals":133,"supplements":134},"2025-02-28",1,2,{"total":28,"last5y":28,"latest":29,"applicants":28},"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":139},[],[],"5bdcea8ee9e98e4de2e7cf1b5adb5467f927a9108874dea3419c319788e760e2","2026-08-24T05:19:21.416523+00:00",{"items":144,"total":28},[],{"items":146,"total":28},[],{"items":148,"total":30},[149,153,156],{"pma_number":22,"supplement_number":150,"trade_name":151,"applicant":152,"decision_date":132},"S002","Ki-67 IHC MIB-1 pharmDx (Dako Omnis)","Agilent Technologies, Inc.",{"pma_number":22,"supplement_number":154,"trade_name":151,"applicant":152,"decision_date":155},"S001","2024-09-04",{"pma_number":22,"supplement_number":9,"trade_name":157,"applicant":152,"decision_date":158},"Ki-67 IHC pharmDx","2021-10-12"]