[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NXG":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":109,"syncDates":110,"translation":117,"marketSummary":124,"recalls":139,"k510s":141,"pmas":143},{"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":21,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":23,"pma_count":25,"event_count":23},5047,"NXG","Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion","3","","Unknown","PA","2","Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":11,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":19,"medical_specialty_description":10,"summary_malfunction_reporting":20},{"pma_number":17},[18],"P050045","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:47.808424+00:00",0,null,5,[],[28,37,45,53,62,70,78,86,94,101],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":34,"vector_similarity":35,"score":36},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","Ⅲ","71059003",0.129252,0.186047,0.624558,0.0307765,{"medical_device_id":38,"generic_name":39,"class_classification":31,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},1153,"体細胞遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","70159013",0.128378,0.160494,0.620608,0.0300905,{"medical_device_id":46,"generic_name":47,"class_classification":31,"jmdn_code":48,"name_similarity":49,"definition_similarity":50,"vector_similarity":51,"score":52},1165,"体細胞遺伝子変異解析セット（抗悪性腫瘍薬適応判定用）","71059023",0.131944,0.165605,0.617346,0.0298507,{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},3510,"免疫蛍光分析装置","Ⅰ","35707010",0.114583,0.163077,0.612622,0.026901,{"medical_device_id":63,"generic_name":64,"class_classification":31,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},1139,"生殖細胞系列遺伝子変異解析プログラム（抗悪性腫瘍薬適応判定用）","71058003",0.123288,0.149254,0.59832,0.0256452,{"medical_device_id":71,"generic_name":72,"class_classification":31,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},1151,"遺伝子変異解析プログラム（がんゲノムプロファイリング検査用）","60943023",0.0873016,0.183333,0.634306,0.0163934,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":77},3190,"ICG蛍光観察装置","Ⅱ","71076002",0.141414,0.189964,0.572193,{"medical_device_id":87,"generic_name":88,"class_classification":31,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},1157,"遺伝子変異解析システム（がんゲノムプロファイリング検査用）","60943033",0.0887097,0.191824,0.632473,0.016129,{"medical_device_id":95,"generic_name":96,"class_classification":81,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":93},1218,"据置型アナログ式汎用一体型X線透視診断装置","37621020",0.144928,0.161017,0.556626,{"medical_device_id":102,"generic_name":103,"class_classification":31,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},1147,"遺伝子変異解析セット（がんゲノムプロファイリング検査用）","60943013",0.0909091,0.2,0.629689,0.015873,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"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":118,"definition_ja":119,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":24,"reviewed_at":24,"created_at":123,"updated_at":123},"トポイソメラーゼIIα遺伝子増幅・欠失検出用蛍光in situハイブリダイゼーション（FISH）キット","トポイソメラーゼIIα（TOP2A）蛍光in situハイブリダイゼーション（FISH）キットは、ホルマリン固定パラフィン包埋ヒト乳がん組織検体を用いて、乳がんにおけるTOP2A遺伝子コピー数の変化（増幅及び欠失）を検出するためのものである。","この製品は米国において最も規制が厳格なクラスIIIに分類されており、市販前に有効性及び安全性に関する科学的な証拠を包括的に示す市販前承認（PMA）の取得が求められます。PMAは510(k)による市販前届出よりも厳格な審査プロセスであり、疾患の診断や治療方針の決定に重大な影響を及ぼす可能性のある機器に適用されます。","claude-sonnet-5","10f470a7de81a921ba6bf932572f69d38e174c5ea5794efd19eaa7d00f19d93a","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":137,"model_name":121,"created_at":138,"updated_at":138},"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4件行われており、最新の判定は2012年6月となっています。不具合報告および回収については、いずれも累計件数が0件で、確認されていません。",{"pma":127,"k510":131,"as_of":132,"events":133,"recalls":134,"top_problems":136},{"latest":128,"originals":129,"supplements":130},"2012-06-01",1,4,{"total":23,"last5y":23,"latest":24,"applicants":23},"2026-08",{"death":23,"other":23,"total":23,"injury":23,"last5y":23,"malfunction":23,"latest_month":24},{"total":23,"last5y":23,"latest":24,"class_i":23,"class_ii":23,"class_iii":23,"top_root_causes":135},[],[],"271b77a87a4e2d809612f0e160ab3af32c8511a4cdb4bc826381d7b8128ef68d","2026-08-24T05:01:48.414996+00:00",{"items":140,"total":23},[],{"items":142,"total":23},[],{"items":144,"total":25},[145,149,153,157,160],{"pma_number":18,"supplement_number":146,"trade_name":147,"applicant":148,"decision_date":128},"S004","TOP2A FISH PHARMADX KIT","Dako Denmark A\u002FS",{"pma_number":18,"supplement_number":150,"trade_name":151,"applicant":148,"decision_date":152},"S003","TOP2A FISH PHARMDX KIT","2011-11-10",{"pma_number":18,"supplement_number":154,"trade_name":155,"applicant":148,"decision_date":156},"S002","TOP2A FISH PHARMDX","2008-03-26",{"pma_number":18,"supplement_number":158,"trade_name":151,"applicant":148,"decision_date":159},"S001","2008-02-13",{"pma_number":18,"supplement_number":9,"trade_name":161,"applicant":148,"decision_date":162},"DAKO TOP2A FISH PHARMDX KIT","2008-01-11"]