[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KXS":3},{"classification":4,"mappedDevices":56,"similarCandidates":57,"relatedClassifications":131,"syncDates":135,"translation":142,"marketSummary":148,"recalls":162,"k510s":164,"pmas":225},{"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":51,"updated_at":52,"recall_count":53,"latest_recall_date":54,"k510_count":55,"pma_count":53,"event_count":53},5462,"KXS","Radioimmunoassay, Methaqualone","2","862.3630","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":48,"product_code":6,"review_panel":10,"gmp_exempt_flag":48,"third_party_flag":49,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":48,"medical_specialty_description":11,"summary_malfunction_reporting":50},{"k_number":17,"fei_number":34,"registration_number":44},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"K843605","K822051","K870935","K011164","K830461","K840164","K812987","K945187","K874272","K921013","K821768","K955676","K874199","K873759","K940123","K993986",[35,36,37,38,39,40,41,42,43],"3005670738","2050010","3003795116","2517506","3006198300","2050012","3010939897","3002806559","3002806560",[45,36,37,38,46,47,39,40,41],"9610126","3005360469","9610529","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:47.318533+00:00",0,null,16,[],[58,66,73,80,87,95,102,109,116,123],{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":53,"vector_similarity":64,"score":65},3555,"ラジオイムノアッセイ用装置","Ⅰ","35506000",0.435897,0.708352,0.0327869,{"medical_device_id":67,"generic_name":68,"class_classification":61,"jmdn_code":69,"name_similarity":70,"definition_similarity":53,"vector_similarity":71,"score":72},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.185185,0.684838,0.0315136,{"medical_device_id":74,"generic_name":75,"class_classification":61,"jmdn_code":76,"name_similarity":77,"definition_similarity":53,"vector_similarity":78,"score":79},3512,"免疫発光測定装置","36223010",0.172414,0.61876,0.030303,{"medical_device_id":81,"generic_name":82,"class_classification":61,"jmdn_code":83,"name_similarity":84,"definition_similarity":53,"vector_similarity":85,"score":86},3513,"移動式免疫発光測定装置","36223020",0.171875,0.615298,0.0290099,{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":53,"vector_similarity":93,"score":94},327,"骨放射線吸収測定装置用放射線源","Ⅲ","38315000",0.129032,0.615885,0.0285714,{"medical_device_id":96,"generic_name":97,"class_classification":61,"jmdn_code":98,"name_similarity":99,"definition_similarity":53,"vector_similarity":100,"score":101},3514,"粒子計測免疫測定装置","70181000",0.169492,0.611821,0.0280392,{"medical_device_id":103,"generic_name":104,"class_classification":61,"jmdn_code":105,"name_similarity":106,"definition_similarity":53,"vector_similarity":107,"score":108},3505,"酵素免疫測定装置","35706010",0.208333,0.595841,0.0276233,{"medical_device_id":110,"generic_name":111,"class_classification":61,"jmdn_code":112,"name_similarity":113,"definition_similarity":53,"vector_similarity":114,"score":115},3508,"免疫比濁分析装置","35926010",0.0925926,0.61782,0.0265533,{"medical_device_id":117,"generic_name":118,"class_classification":61,"jmdn_code":119,"name_similarity":120,"definition_similarity":53,"vector_similarity":121,"score":122},3509,"移動式免疫比濁分析装置","35926020",0.1,0.613768,0.0265471,{"medical_device_id":124,"generic_name":125,"class_classification":126,"jmdn_code":127,"name_similarity":128,"definition_similarity":53,"vector_similarity":129,"score":130},1283,"RI動態機能検査装置","Ⅱ","70008000",0.0694444,0.649405,0.015873,[132],{"product_code":133,"device_name":134,"device_class":8,"k510_count":53},"PVF","Test, Methaqualone, Employment And Insurance Testing, Exempt",{"510k":136,"classification":137,"enforcement":138,"event":139,"pma":140,"warning_letter":141},"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":143,"definition_ja":54,"commentary_ja":144,"model_name":145,"source_hash":146,"reviewed_by":54,"reviewed_at":54,"created_at":147,"updated_at":147},"メサクアロン測定用ラジオイムノアッセイ","本品は、生体試料中のメサクアロン（鎮静催眠薬の一種）を検出・定量するための放射免疫測定法（ラジオイムノアッセイ）を用いた体外診断用機器です。米国ではクラスIIに分類されており、市販に際しては510(k)による市販前届出が必要とされ、既存の同等品との実質的同等性を示すことで販売が認められる区分に位置づけられています。","claude-sonnet-5","8a1948004fb7e0e1a544ecf13e7ee1d2419d486b6655b6c2358bf28b2fa451c7","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":149,"stats":150,"stats_hash":160,"model_name":145,"created_at":161,"updated_at":161},"本製品分野における510(k)の累計件数は16件、参入企業数は7社となっておりますが、直近5年間の届出実績はなく、最新の判定は2001年5月です。PMAの承認事例、不具合報告、回収のいずれについても実績は確認されていません。",{"pma":151,"k510":152,"as_of":155,"events":156,"recalls":157,"top_problems":159},{"latest":54,"originals":53,"supplements":53},{"total":55,"last5y":53,"latest":153,"applicants":154},"2001-05-10",7,"2026-08",{"death":53,"other":53,"total":53,"injury":53,"last5y":53,"malfunction":53,"latest_month":54},{"total":53,"last5y":53,"latest":54,"class_i":53,"class_ii":53,"class_iii":53,"top_root_causes":158},[],[],"c45dba9fc0a02a0eb986ae259be256b807c84da890b20d631b64255d0f83986a","2026-08-24T04:49:04.081036+00:00",{"items":163,"total":53},[],{"items":165,"total":55},[166,172,177,181,186,190,193,196,199,203,206,209,212,216,219,222],{"k_number":21,"device_name":167,"applicant":168,"decision_date":153,"clearance_type":169,"decision_code":170,"statement_or_summary":171},"MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229","Syva Co., Dade Behring, Inc.","Special","SESE","Summary",{"k_number":33,"device_name":173,"applicant":174,"decision_date":175,"clearance_type":176,"decision_code":170,"statement_or_summary":171},"SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL\u002F9Q129UL","Syva Co.","2000-01-27","Traditional",{"k_number":29,"device_name":178,"applicant":179,"decision_date":180,"clearance_type":176,"decision_code":170,"statement_or_summary":171},"SYNCHRON SYSTEMS METHAQUALONE REAGENT","Beckman Instruments, Inc.","1996-03-04",{"k_number":25,"device_name":182,"applicant":183,"decision_date":184,"clearance_type":176,"decision_code":170,"statement_or_summary":185},"ROCHE ABUSCREEN ONLINE FOR METHAQUALONE","Roche Diagnostic Systems, Inc.","1995-04-05","Statement",{"k_number":32,"device_name":187,"applicant":188,"decision_date":189,"clearance_type":176,"decision_code":170,"statement_or_summary":185},"METHAQUALONE ENZYME IMMUNOASSAY","Diagnostic Reagents, Inc.","1994-05-03",{"k_number":27,"device_name":191,"applicant":174,"decision_date":192,"clearance_type":176,"decision_code":170,"statement_or_summary":171},"SYVA EMIT II METHAQUALONE ASSAY","1992-05-13",{"k_number":26,"device_name":194,"applicant":183,"decision_date":195,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"REVISED LABELING FOR METHAQUALONE TEST KIT","1987-11-13",{"k_number":30,"device_name":197,"applicant":174,"decision_date":198,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"REVISED LABELING FOR SYVA METHAQUALONE ASSAYS","1987-10-28",{"k_number":31,"device_name":200,"applicant":201,"decision_date":202,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"LABELING CHANGE COAT-A-COUNT METHAQUALONE","Diagnostic Products Corp.","1987-10-15",{"k_number":20,"device_name":204,"applicant":201,"decision_date":205,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"COAT-A-COUNT METHAQUALONE TKMQ1","1987-03-19",{"k_number":18,"device_name":207,"applicant":174,"decision_date":208,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"EMIT 700 METHAQUALONE ASSAY","1984-10-05",{"k_number":23,"device_name":210,"applicant":174,"decision_date":211,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"EMIT ST URINE METHAQUALONE ASSAY","1984-03-22",{"k_number":22,"device_name":213,"applicant":214,"decision_date":215,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE","Hoffmann-La Roche, Inc.","1983-03-24",{"k_number":19,"device_name":217,"applicant":174,"decision_date":218,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"EMIT D.A.V. METHAQUALONE ASSAY","1982-07-27",{"k_number":28,"device_name":220,"applicant":174,"decision_date":221,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"EMIT ST URINE METHAGUALONE ASSAY","1982-06-24",{"k_number":24,"device_name":223,"applicant":214,"decision_date":224,"clearance_type":176,"decision_code":170,"statement_or_summary":54},"AGGLUTEX METHAQUALONE TEST KIT","1981-12-22",{"items":226,"total":53},[]]