[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DMY":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":101,"syncDates":135,"translation":142,"marketSummary":148,"recalls":161,"k510s":163,"pmas":171},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},1109,"DMY","Gas Chromatography, Morphine","2","862.3640","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"K990409","N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:47.656965+00:00",0,null,1,[],[29,37,44,52,59,66,73,81,88,94],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},2557,"ガス式トレパン","Ⅱ","32724000",0.166667,0.632423,0.0307765,{"medical_device_id":38,"generic_name":39,"class_classification":32,"jmdn_code":40,"name_similarity":41,"definition_similarity":24,"vector_similarity":42,"score":43},1514,"マルチガスモジュール","37061000",0.157895,0.620101,0.0289916,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},3532,"メタンガス分析装置","Ⅰ","17477000",0.139535,0.686147,0.0278877,{"medical_device_id":53,"generic_name":54,"class_classification":47,"jmdn_code":55,"name_similarity":56,"definition_similarity":24,"vector_similarity":57,"score":58},3518,"高速液体クロマトグラフィ分析装置","36420000",0.245902,0.593979,0.0275046,{"medical_device_id":60,"generic_name":61,"class_classification":32,"jmdn_code":62,"name_similarity":63,"definition_similarity":24,"vector_similarity":64,"score":65},1588,"X線CT診断装置キセノンガス管理システム","40907000",0.150685,0.618276,0.0274436,{"medical_device_id":67,"generic_name":68,"class_classification":32,"jmdn_code":69,"name_similarity":70,"definition_similarity":24,"vector_similarity":71,"score":72},1584,"一酸化炭素ガス分析装置","35467000",0.14,0.631336,0.0270125,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":24,"vector_similarity":79,"score":80},727,"人工心肺用ライン内血液ガスモニタ","Ⅲ","31685000",0.140351,0.618633,0.0265409,{"medical_device_id":82,"generic_name":83,"class_classification":76,"jmdn_code":84,"name_similarity":85,"definition_similarity":24,"vector_similarity":86,"score":87},409,"脊髄造影キット","35199000",0.189189,0.492079,0.016129,{"medical_device_id":89,"generic_name":90,"class_classification":32,"jmdn_code":91,"name_similarity":92,"definition_similarity":24,"vector_similarity":93,"score":87},1573,"炭酸ガス分析装置","31339000",0.0980392,0.643452,{"medical_device_id":95,"generic_name":96,"class_classification":32,"jmdn_code":97,"name_similarity":98,"definition_similarity":24,"vector_similarity":99,"score":100},1924,"胆管造影用カテーテル","16429000",0.181818,0.506072,0.015873,[102,106,110,114,117,120,123,126,129,132],{"product_code":103,"device_name":104,"device_class":8,"k510_count":105},"DOE","Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.",12,{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"DNK","Thin Layer Chromatography, Morphine",4,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"DLR","Hemagglutination Inhibition, Morphine",2,{"product_code":115,"device_name":116,"device_class":8,"k510_count":113},"DPK","Liquid Chromatography, Morphine",{"product_code":118,"device_name":119,"device_class":8,"k510_count":26},"DJJ","Fluorometry, Morphine",{"product_code":121,"device_name":122,"device_class":8,"k510_count":26},"DOK","Free Radical Assay, Morphine",{"product_code":124,"device_name":125,"device_class":8,"k510_count":24},"DIQ","Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.",{"product_code":127,"device_name":128,"device_class":8,"k510_count":24},"DNA","Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody",{"product_code":130,"device_name":131,"device_class":8,"k510_count":24},"NGI","Test, Morphine, Over The Counter",{"product_code":133,"device_name":134,"device_class":8,"k510_count":24},"PVG","Test, Morphine, 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":25,"commentary_ja":144,"model_name":145,"source_hash":146,"reviewed_by":25,"reviewed_at":25,"created_at":147,"updated_at":147},"モルヒネ用ガスクロマトグラフィー分析装置","本品は、生体試料中に含まれるモルヒネをガスクロマトグラフィーにより分析するための機器です。米国ではクラス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ことが求められています。クラスIIは中程度のリスクを有する医療機器に対する区分であり、特別要件（スペシャルコントロール）を満たすことで安全性と有効性が担保される仕組みとなっています。","claude-sonnet-5","0fe2f57952d08716dc91b52a69320a6de055b6215cb80d4fb23f81a95252b15d","2026-08-24T01:47:50.38553+00:00",{"product_code":6,"summary_ja":149,"stats":150,"stats_hash":159,"model_name":145,"created_at":160,"updated_at":160},"本製品コードの510(k)届出は累計1件で、参入企業は1社にとどまり、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（MDR）については累計報告件数が0件であり、報告事例は確認されていません。回収についても累計件数0件で、クラスI〜IIIいずれの区分でも該当はなく、直近5年間の回収も確認されていません。",{"pma":151,"k510":152,"as_of":154,"events":155,"recalls":156,"top_problems":158},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":153,"applicants":26},"1999-04-15","2026-08",{"death":24,"other":24,"total":24,"injury":24,"last5y":24,"malfunction":24,"latest_month":25},{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":157},[],[],"d2ca0c3f2fc7b4ab79679f558975cc80edd99d0c29111e2aeb9ec98b92147287","2026-08-24T04:12:57.498101+00:00",{"items":162,"total":24},[],{"items":164,"total":26},[165],{"k_number":18,"device_name":166,"applicant":167,"decision_date":153,"clearance_type":168,"decision_code":169,"statement_or_summary":170},"ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)","Roche Diagnostics Corp.","Traditional","SESE","Summary",{"items":172,"total":24},[]]