[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QTE":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":110,"syncDates":171,"translation":178,"marketSummary":185,"recalls":198,"k510s":200,"pmas":208},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},4609,"QTE","Thymidine Kinase Activity","2","866.6010","IM","Immunology","1","In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":22,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":22,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17,"fei_number":19,"registration_number":21},[18],"K202852",[20],"3008629194",[20],"","N","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.758894+00:00",0,null,1,[],[32,41,49,58,65,73,80,88,95,103],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},1560,"長時間身体活動データレコーダ","Ⅱ","36252000",0.172414,0.144928,0.520422,0.0163934,{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":40},3577,"血液培養自動分析装置","Ⅰ","35617000",0.0175439,0.130548,0.638638,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},805,"酸素治療アクチベータ","Ⅲ","37230000",0.159091,0.148148,0.504122,0.016129,{"medical_device_id":59,"generic_name":60,"class_classification":44,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":57},3511,"移動式免疫蛍光分析装置","35707020",0.0169492,0.156863,0.632768,{"medical_device_id":66,"generic_name":67,"class_classification":35,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},1283,"RI動態機能検査装置","70008000",0.028169,0.135371,0.629877,0.015873,{"medical_device_id":74,"generic_name":75,"class_classification":35,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":72},1459,"マップ脳波計","11467020",0.155172,0.158192,0.56139,{"medical_device_id":81,"generic_name":82,"class_classification":52,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},965,"治療用能動器具","70666000",0.142857,0.085,0.506809,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":44,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":87},3510,"免疫蛍光分析装置","35707010",0.0192308,0.153846,0.629673,{"medical_device_id":96,"generic_name":97,"class_classification":52,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},417,"ウロキナーゼ使用排液用チューブ","14191303",0.125,0.143617,0.494899,0.0153846,{"medical_device_id":104,"generic_name":105,"class_classification":44,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":102},3555,"ラジオイムノアッセイ用装置","35506000",0.0196078,0.134557,0.618951,[111,115,119,122,126,130,134,138,142,146,150,153,156,159,162,165,168],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"LTJ","Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers",34,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"DHX","System, Test, Carcinoembryonic Antigen",28,{"product_code":120,"device_name":121,"device_class":8,"k510_count":118},"MOI","System, Test, Immunological, Antigen, Tumor",{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"LTK","Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)",26,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"LOJ","Kit, Test,Alpha-Fetoprotein For Testicular Cancer",17,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"MSW","System, Test, Thyroglobulin",13,{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"NIG","System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer",11,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"MMW","System, Test, Tumor Marker, Monitoring, Bladder",9,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"OIU","Test, Epithelial Ovarian Tumor Associated Antigen (He4)",5,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"NCW","System, Test, Her-2\u002FNeu, Monitoring",3,{"product_code":151,"device_name":152,"device_class":8,"k510_count":149},"OVK","Cytokeratin Fragments 21-1 Eia Kit",{"product_code":154,"device_name":155,"device_class":8,"k510_count":29},"LOQ","Device, General Purpose, Hematology",{"product_code":157,"device_name":158,"device_class":8,"k510_count":29},"NTY","System, Test, Fibrin\u002FFibrinogen Degradation Products For Monitoring Of Colorectal Cancer",{"product_code":160,"device_name":161,"device_class":8,"k510_count":29},"OXP","Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment",{"product_code":163,"device_name":164,"device_class":8,"k510_count":29},"QXS","Chromogranin A",{"product_code":166,"device_name":167,"device_class":8,"k510_count":27},"MUT","Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)",{"product_code":169,"device_name":170,"device_class":8,"k510_count":27},"NVA","Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma",{"510k":172,"classification":173,"enforcement":174,"event":175,"pma":176,"warning_letter":177},"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":179,"definition_ja":180,"commentary_ja":181,"model_name":182,"source_hash":183,"reviewed_by":28,"reviewed_at":28,"created_at":184,"updated_at":184},"チミジンキナーゼ活性測定キット","乳癌患者の疾患進行のモニタリングを補助するため、チミジンキナーゼ活性（TKa）を測定するインビトロ試験である。","本品は米国においてクラスIIに分類される体外診断用医療機器であり、市販前届出（510(k)）による審査を経て市場に流通することができます。クラスIIは中程度のリスクを有する機器区分であり、既存の同等品（predicate device）との実質的同等性を示すことにより市販前届出（510(k)）で対応可能とされています。","claude-sonnet-5","c0eb9b2f076bd20aba21084255fcee45e58644fa7772e7becf1bd7b819f3ae1f","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":186,"stats":187,"stats_hash":196,"model_name":182,"created_at":197,"updated_at":197},"本製品コードは510(k)による市販前届出区分で、累計届出件数は1件、参入企業数は1社となっており、直近5年でも1件の届出が確認されています。不具合報告および回収については、いずれも累計0件で、確認されていません。",{"pma":188,"k510":189,"as_of":191,"events":192,"recalls":193,"top_problems":195},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":29,"latest":190,"applicants":29},"2022-07-29","2026-08",{"death":27,"other":27,"total":27,"injury":27,"last5y":27,"malfunction":27,"latest_month":28},{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":194},[],[],"e09830e65f0cad0e24a3131eb660da9281e1ffd5d7200e95ed497f67a44d754c","2026-08-24T05:21:03.140427+00:00",{"items":199,"total":27},[],{"items":201,"total":29},[202],{"k_number":18,"device_name":203,"applicant":204,"decision_date":190,"clearance_type":205,"decision_code":206,"statement_or_summary":207},"DiviTum TKa","Biovica International AB","Traditional","SESE","Summary",{"items":209,"total":27},[]]