[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MLE":3},{"classification":4,"mappedDevices":33,"similarCandidates":34,"relatedClassifications":106,"syncDates":111,"translation":118,"marketSummary":124,"recalls":137,"k510s":139,"pmas":155},{"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":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":32,"pma_count":30,"event_count":30},5246,"MLE","Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control","2","866.5110","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":10,"gmp_exempt_flag":25,"third_party_flag":26,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":27},{"k_number":17,"fei_number":21,"registration_number":24},[18,19,20],"K991942","K951206","K010558",[22,23],"3012348571","2026994",[22,23],"N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:48.493322+00:00",0,null,3,[],[35,43,50,57,64,71,78,85,92,99],{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":30,"vector_similarity":41,"score":42},3505,"酵素免疫測定装置","Ⅰ","35706010",0.35,0.736568,0.0327869,{"medical_device_id":44,"generic_name":45,"class_classification":38,"jmdn_code":46,"name_similarity":47,"definition_similarity":30,"vector_similarity":48,"score":49},3506,"移動式酵素免疫測定装置","35706020",0.313433,0.7354,0.0322581,{"medical_device_id":51,"generic_name":52,"class_classification":38,"jmdn_code":53,"name_similarity":54,"definition_similarity":30,"vector_similarity":55,"score":56},3514,"粒子計測免疫測定装置","70181000",0.243243,0.658681,0.0307984,{"medical_device_id":58,"generic_name":59,"class_classification":38,"jmdn_code":60,"name_similarity":61,"definition_similarity":30,"vector_similarity":62,"score":63},3535,"酵素分析装置","35470000",0.15,0.667361,0.0303658,{"medical_device_id":65,"generic_name":66,"class_classification":38,"jmdn_code":67,"name_similarity":68,"definition_similarity":30,"vector_similarity":69,"score":70},3555,"ラジオイムノアッセイ用装置","35506000",0.179104,0.661083,0.03031,{"medical_device_id":72,"generic_name":73,"class_classification":38,"jmdn_code":74,"name_similarity":75,"definition_similarity":30,"vector_similarity":76,"score":77},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.208333,0.643057,0.0297095,{"medical_device_id":79,"generic_name":80,"class_classification":38,"jmdn_code":81,"name_similarity":82,"definition_similarity":30,"vector_similarity":83,"score":84},3512,"免疫発光測定装置","36223010",0.197368,0.644529,0.0296703,{"medical_device_id":86,"generic_name":87,"class_classification":38,"jmdn_code":88,"name_similarity":89,"definition_similarity":30,"vector_similarity":90,"score":91},3513,"移動式免疫発光測定装置","36223020",0.180723,0.649912,0.0296443,{"medical_device_id":93,"generic_name":94,"class_classification":38,"jmdn_code":95,"name_similarity":96,"definition_similarity":30,"vector_similarity":97,"score":98},3567,"イムノアッセイ用検体前処理装置","30870000",0.171429,0.657013,0.0294118,{"medical_device_id":100,"generic_name":101,"class_classification":38,"jmdn_code":102,"name_similarity":103,"definition_similarity":30,"vector_similarity":104,"score":105},3510,"免疫蛍光分析装置","35707010",0.111111,0.665565,0.026861,[107],{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"DBJ","Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control",2,{"510k":112,"classification":113,"enforcement":114,"event":115,"pma":116,"warning_letter":117},"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":119,"definition_ja":31,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":31,"reviewed_at":31,"created_at":123,"updated_at":123},"抗胃壁細胞抗体酵素免疫測定キット（抗原・コントロール）","この製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)）による審査区分が適用されます。510(k)は、既存の同等性のある医療機器（predicate device）との実質的同等性を示すことで市販が認められる仕組みであり、クラスIIIの機器に適用される市販前承認（PMA）と比較して、審査上求められる証明の程度が異なります。","claude-sonnet-5","2f27c59e422b5de689ebf68853dcbe48c46e34506715541acaf6146e764a1b24","2026-08-24T02:14:44.518901+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":135,"model_name":121,"created_at":136,"updated_at":136},"510(k)の累計届出件数は3件で、3社が参入していますが、直近5年間の届出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、いずれも累計件数が0件であり、報告・実績は確認されていません。",{"pma":127,"k510":128,"as_of":130,"events":131,"recalls":132,"top_problems":134},{"latest":31,"originals":30,"supplements":30},{"total":32,"last5y":30,"latest":129,"applicants":32},"2001-04-03","2026-08",{"death":30,"other":30,"total":30,"injury":30,"last5y":30,"malfunction":30,"latest_month":31},{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":133},[],[],"2bfc7eb8ce1e6b9ed272e4bd4647719f54beca72d090721a0b5e8f452aba4262","2026-08-24T04:54:58.317174+00:00",{"items":138,"total":30},[],{"items":140,"total":32},[141,147,151],{"k_number":20,"device_name":142,"applicant":143,"decision_date":129,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA","Inova Diagnostics, Inc.","Traditional","SESE","Statement",{"k_number":18,"device_name":148,"applicant":149,"decision_date":150,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA","Cogent Diagnotics , Ltd.","1999-08-24",{"k_number":19,"device_name":152,"applicant":153,"decision_date":154,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"VARELISA PARIETAL CELL ANTIBODIES","Elias U.S.A., Inc.","1995-04-17",{"items":156,"total":30},[]]