[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DJD":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":109,"syncDates":128,"translation":135,"marketSummary":141,"recalls":155,"k510s":157,"pmas":191},{"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":32,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":36,"pma_count":34,"event_count":34},4831,"DJD","Enzyme Immunoassay, Primidone","2","862.3680","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":29,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":30,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":31},{"k_number":17,"fei_number":26,"registration_number":28},[18,19,20,21,22,23,24,25],"K973582","K781957","K910527","K832798","K820138","K802654","K813597","K840939",[27],"2517506",[27],"N","Y","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.882786+00:00",0,null,8,[],[39,47,53,60,67,74,81,88,95,102],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":34,"vector_similarity":45,"score":46},3505,"酵素免疫測定装置","Ⅰ","35706010",0.5,0.675944,0.0325225,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":34,"vector_similarity":52,"score":46},3506,"移動式酵素免疫測定装置","35706020",0.422222,0.676382,{"medical_device_id":54,"generic_name":55,"class_classification":42,"jmdn_code":56,"name_similarity":57,"definition_similarity":34,"vector_similarity":58,"score":59},3555,"ラジオイムノアッセイ用装置","35506000",0.222222,0.623323,0.030303,{"medical_device_id":61,"generic_name":62,"class_classification":42,"jmdn_code":63,"name_similarity":64,"definition_similarity":34,"vector_similarity":65,"score":66},3535,"酵素分析装置","35470000",0.184211,0.624056,0.0298774,{"medical_device_id":68,"generic_name":69,"class_classification":42,"jmdn_code":70,"name_similarity":71,"definition_similarity":34,"vector_similarity":72,"score":73},3512,"免疫発光測定装置","36223010",0.218182,0.622362,0.0298507,{"medical_device_id":75,"generic_name":76,"class_classification":42,"jmdn_code":77,"name_similarity":78,"definition_similarity":34,"vector_similarity":79,"score":80},3514,"粒子計測免疫測定装置","70181000",0.236364,0.60353,0.0297095,{"medical_device_id":82,"generic_name":83,"class_classification":42,"jmdn_code":84,"name_similarity":85,"definition_similarity":34,"vector_similarity":86,"score":87},3567,"イムノアッセイ用検体前処理装置","30870000",0.318182,0.59874,0.0292063,{"medical_device_id":89,"generic_name":90,"class_classification":42,"jmdn_code":91,"name_similarity":92,"definition_similarity":34,"vector_similarity":93,"score":94},3513,"移動式免疫発光測定装置","36223020",0.193548,0.619299,0.0291986,{"medical_device_id":96,"generic_name":97,"class_classification":42,"jmdn_code":98,"name_similarity":99,"definition_similarity":34,"vector_similarity":100,"score":101},3510,"免疫蛍光分析装置","35707010",0.12,0.598996,0.0279843,{"medical_device_id":103,"generic_name":104,"class_classification":42,"jmdn_code":105,"name_similarity":106,"definition_similarity":34,"vector_similarity":107,"score":108},3508,"免疫比濁分析装置","35926010",0.115385,0.598954,0.027598,[110,113,116,119,122,125],{"product_code":111,"device_name":112,"device_class":8,"k510_count":36},"LFT","Fluorescent Immunoassay, Primidone",{"product_code":114,"device_name":115,"device_class":8,"k510_count":34},"DIL","Radioimmunoassay, Primidone",{"product_code":117,"device_name":118,"device_class":8,"k510_count":34},"DMQ","Gas Chromatography, Primidone",{"product_code":120,"device_name":121,"device_class":8,"k510_count":34},"DOS","Thin Layer Chromatography, Primidone",{"product_code":123,"device_name":124,"device_class":8,"k510_count":34},"DPQ","Liquid Chromatography, Primidone",{"product_code":126,"device_name":127,"device_class":8,"k510_count":34},"LCZ","U.V. Spectrometry, Primidone",{"510k":129,"classification":130,"enforcement":131,"event":132,"pma":133,"warning_letter":134},"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":136,"definition_ja":35,"commentary_ja":137,"model_name":138,"source_hash":139,"reviewed_by":35,"reviewed_at":35,"created_at":140,"updated_at":140},"プリミドン測定用酵素免疫測定キット","この製品は、米国FDAの規制上クラスIIに分類される医療機器であり、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求められます。クラスIIは中程度のリスクを有する機器区分であり、一般的な管理に加えて特別な管理措置が必要とされ、既存の同等製品との実質的同等性を示すことで承認されます。","claude-sonnet-5","eee3a0507c9be34d3a023f8e843e1c06b3f16d51e3f891cea245a3e5b46f101f","2026-08-24T01:47:50.38553+00:00",{"product_code":6,"summary_ja":142,"stats":143,"stats_hash":153,"model_name":138,"created_at":154,"updated_at":154},"本製品コードでは、510(k)による届出が累計8件、参入企業数は6社となっていますが、直近5年間の届出実績や最新の判定（1997年11月以降）はありません。PMAによる承認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、報告や回収の実績は確認されていません。",{"pma":144,"k510":145,"as_of":148,"events":149,"recalls":150,"top_problems":152},{"latest":35,"originals":34,"supplements":34},{"total":36,"last5y":34,"latest":146,"applicants":147},"1997-11-12",6,"2026-08",{"death":34,"other":34,"total":34,"injury":34,"last5y":34,"malfunction":34,"latest_month":35},{"total":34,"last5y":34,"latest":35,"class_i":34,"class_ii":34,"class_iii":34,"top_root_causes":151},[],[],"4a4616c0a145e71cd322b5f88b6d78d2852783a292879fa6018ab93d9f97a8fb","2026-08-24T04:12:57.498101+00:00",{"items":156,"total":34},[],{"items":158,"total":36},[159,165,169,172,175,179,183,187],{"k_number":18,"device_name":160,"applicant":161,"decision_date":146,"clearance_type":162,"decision_code":163,"statement_or_summary":164},"ACE PRIMIDONE REAGENT, AED CALIBRATORS","Schiapparelli Biosystems, Inc.","Traditional","SESE","Summary",{"k_number":20,"device_name":166,"applicant":167,"decision_date":168,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE","Syva Co.","1991-03-14",{"k_number":25,"device_name":170,"applicant":167,"decision_date":171,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"EMIT QST PRIMIDONE ASSAY","1984-04-24",{"k_number":21,"device_name":173,"applicant":167,"decision_date":174,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"MODIFICA-OF EMIT AED PRIMIDONE ASSAY","1983-10-14",{"k_number":22,"device_name":176,"applicant":177,"decision_date":178,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"PRIMIDONE REAGENT TEST KIT","Beckman Instruments, Inc.","1982-01-28",{"k_number":24,"device_name":180,"applicant":181,"decision_date":182,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"TDX PRIMIDONE","Abbott Laboratories","1982-01-22",{"k_number":23,"device_name":184,"applicant":185,"decision_date":186,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"AMES TDA PRIMIDONE TEST","Miles Laboratories, Inc.","1980-11-12",{"k_number":19,"device_name":188,"applicant":189,"decision_date":190,"clearance_type":162,"decision_code":163,"statement_or_summary":35},"ANALYTICAL TEST PACK, PRIMIDONE","E.I. Dupont DE Nemours & Co., Inc.","1979-01-10",{"items":192,"total":34},[]]