[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SFC":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"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":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},5859,"SFC","Neurologic Disease Risk Assessment Molecular Test","2","866.5850","IM","Immunology","1","A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and\u002For with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.",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],"DEN240032",[20],"3009523773",[20],"","N","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:47.949024+00:00",0,null,1,[],[32,41,49,57,65,74,82,91,100,108],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},1601,"神経疾患診断用定量的感覚検査器","Ⅱ","37349000",0.175824,0.287879,0.686672,0.0320184,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3144,"神経疾患診断用定量的感覚検査器用プログラム","37349012",0.15534,0.208571,0.654598,0.0298507,{"medical_device_id":50,"generic_name":51,"class_classification":35,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},1630,"生理学的神経筋機能分析装置","17929000",0.189873,0.210638,0.639134,0.0295716,{"medical_device_id":58,"generic_name":59,"class_classification":35,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},1396,"睡眠評価装置","33843000",0.193548,0.209163,0.621851,0.0287873,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},3423,"関節運動テスタ","Ⅰ","36148000",0.145161,0.188406,0.615569,0.0270516,{"medical_device_id":75,"generic_name":76,"class_classification":35,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},1283,"RI動態機能検査装置","70008000",0.114943,0.20354,0.608131,0.0227273,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},123,"脳室向け脳神経外科用カテーテル","Ⅳ","32585010",0.217391,0.107784,0.495722,0.0163934,{"medical_device_id":92,"generic_name":93,"class_classification":94,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},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",0.0225564,0.216285,0.671522,0.016129,{"medical_device_id":101,"generic_name":102,"class_classification":94,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},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",0.0230769,0.191257,0.66999,0.015873,{"medical_device_id":109,"generic_name":110,"class_classification":94,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},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",0.00961538,0.206989,0.666864,0.015625,[],{"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":28,"reviewed_at":28,"created_at":130,"updated_at":130},"神経疾患発症リスク評価分子検査","神経疾患素因リスク評価システムは、ヒト検体中のDNA、RNA、又はタンパク質のバリアントを検出又は測定することを目的とした処方箋対象の体外診断用機器である。当該測定値は、症状及び／又は疾患関連リスク因子を呈する患者における神経疾患発症リスクの評価を補助し、他の臨床検査情報及び臨床情報と併せて患者管理を支援するために用いられる。","本品は米国においてクラスIIに分類され、市販前届出（510(k)）による審査を経て市場に流通する体外診断用医療機器です。クラスIIは中程度のリスクを有する機器に対する区分であり、性能に関する特別要件（スペシャルコントロール）を満たすことにより、既存の同等機器との実質的同等性を示す510(k)手続きでの承認申請が可能とされています。","claude-sonnet-5","7bed529df713e3e3548e22bbcc3078ca09c8eaaf2e3ba15b5b7d2d7a52bdcf76","2026-08-24T03:40:21.731962+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、直近5年間も1件となっており、参入企業数は1社です。不具合報告および回収については、いずれも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":28,"originals":27,"supplements":27},{"total":29,"last5y":29,"latest":136,"applicants":29},"2025-06-12","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":140},[],[],"f97e88547bb9c05cf7246fa30af65a72d9eae2e0b8bd6db4e15756f023a8d6d4","2026-08-24T05:23:16.025025+00:00",{"items":145,"total":27},[],{"items":147,"total":29},[148],{"k_number":18,"device_name":149,"applicant":150,"decision_date":136,"clearance_type":151,"decision_code":152,"statement_or_summary":28},"APO-Easy Genotyping kit","Firalis SA","Direct","DENG",{"items":154,"total":27},[]]