[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DOE":3},{"classification":4,"mappedDevices":42,"similarCandidates":43,"relatedClassifications":117,"syncDates":151,"translation":158,"marketSummary":164,"recalls":178,"k510s":180,"pmas":227},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":39,"event_count":39},2633,"DOE","Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.","2","862.3640","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":34,"product_code":6,"review_panel":10,"gmp_exempt_flag":34,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":34,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":30,"registration_number":32},[18,19,20,21,22,23,24,25,26,27,28,29],"K951319","K830460","K881102","K863913","K864168","K935055","K010080","K933572","K011011","K010079","K002418","K830462",[31],"3001452245",[33],"2060833","N","Y","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:48.225237+00:00",0,null,12,[],[44,52,59,66,73,80,87,94,101,109],{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":39,"vector_similarity":50,"score":51},3555,"ラジオイムノアッセイ用装置","Ⅰ","35506000",0.263889,0.659587,0.0327869,{"medical_device_id":53,"generic_name":54,"class_classification":47,"jmdn_code":55,"name_similarity":56,"definition_similarity":39,"vector_similarity":57,"score":58},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.151163,0.637792,0.0305789,{"medical_device_id":60,"generic_name":61,"class_classification":47,"jmdn_code":62,"name_similarity":63,"definition_similarity":39,"vector_similarity":64,"score":65},3506,"移動式酵素免疫測定装置","35706020",0.176471,0.585461,0.0298277,{"medical_device_id":67,"generic_name":68,"class_classification":47,"jmdn_code":69,"name_similarity":70,"definition_similarity":39,"vector_similarity":71,"score":72},3514,"粒子計測免疫測定装置","70181000",0.155556,0.597785,0.0296313,{"medical_device_id":74,"generic_name":75,"class_classification":47,"jmdn_code":76,"name_similarity":77,"definition_similarity":39,"vector_similarity":78,"score":79},3505,"酵素免疫測定装置","35706010",0.1625,0.588344,0.0292735,{"medical_device_id":81,"generic_name":82,"class_classification":47,"jmdn_code":83,"name_similarity":84,"definition_similarity":39,"vector_similarity":85,"score":86},3513,"移動式免疫発光測定装置","36223020",0.170213,0.584016,0.0289583,{"medical_device_id":88,"generic_name":89,"class_classification":47,"jmdn_code":90,"name_similarity":91,"definition_similarity":39,"vector_similarity":92,"score":93},3509,"移動式免疫比濁分析装置","35926020",0.0978261,0.602449,0.0287179,{"medical_device_id":95,"generic_name":96,"class_classification":47,"jmdn_code":97,"name_similarity":98,"definition_similarity":39,"vector_similarity":99,"score":100},3512,"免疫発光測定装置","36223010",0.157303,0.585454,0.028665,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":39,"vector_similarity":107,"score":108},327,"骨放射線吸収測定装置用放射線源","Ⅲ","38315000",0.09375,0.583355,0.0256579,{"medical_device_id":110,"generic_name":111,"class_classification":112,"jmdn_code":113,"name_similarity":114,"definition_similarity":39,"vector_similarity":115,"score":116},2997,"自己検査用尿化学分析器","Ⅱ","70186000",0.0869565,0.588519,0.0255788,[118,122,126,129,133,136,139,142,145,148],{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"DNK","Thin Layer Chromatography, Morphine",4,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"DLR","Hemagglutination Inhibition, Morphine",2,{"product_code":127,"device_name":128,"device_class":8,"k510_count":125},"DPK","Liquid Chromatography, Morphine",{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"DJJ","Fluorometry, Morphine",1,{"product_code":134,"device_name":135,"device_class":8,"k510_count":132},"DMY","Gas Chromatography, Morphine",{"product_code":137,"device_name":138,"device_class":8,"k510_count":132},"DOK","Free Radical Assay, Morphine",{"product_code":140,"device_name":141,"device_class":8,"k510_count":39},"DIQ","Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.",{"product_code":143,"device_name":144,"device_class":8,"k510_count":39},"DNA","Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody",{"product_code":146,"device_name":147,"device_class":8,"k510_count":39},"NGI","Test, Morphine, Over The Counter",{"product_code":149,"device_name":150,"device_class":8,"k510_count":39},"PVG","Test, Morphine, Employment And Insurance Testing, Exempt",{"510k":152,"classification":153,"enforcement":154,"event":155,"pma":156,"warning_letter":157},"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":159,"definition_ja":40,"commentary_ja":160,"model_name":161,"source_hash":162,"reviewed_by":40,"reviewed_at":40,"created_at":163,"updated_at":163},"モルヒネ測定用ラジオイムノアッセイ（125-I標識、ヤギ抗体・硫酸アンモニウム分離法）","本品は、ヨウ素125で標識したモルヒネ抗原とヤギ抗体を用い、硫酸アンモニウム沈殿法により結合型と遊離型を分離して、検体中のモルヒネ濃度を放射免疫測定法により測定する体外診断用医薬品です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て、既存の同等な機器との実質的同等性が確認されることで市販が認められます。","claude-sonnet-5","a53dee05c8bfbb17e5828aa147e7d7a9c9a6085f3a2cb3828e6fe5017dbdc37b","2026-08-24T01:47:50.38553+00:00",{"product_code":6,"summary_ja":165,"stats":166,"stats_hash":176,"model_name":161,"created_at":177,"updated_at":177},"510(k)の累計件数は12件、参入企業数は8社ですが、直近5年間の届出はなく、最新の判定は2001年5月です。PMAでの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0件で確認されていません。",{"pma":167,"k510":168,"as_of":171,"events":172,"recalls":173,"top_problems":175},{"latest":40,"originals":39,"supplements":39},{"total":41,"last5y":39,"latest":169,"applicants":170},"2001-05-29",8,"2026-08",{"death":39,"other":39,"total":39,"injury":39,"last5y":39,"malfunction":39,"latest_month":40},{"total":39,"last5y":39,"latest":40,"class_i":39,"class_ii":39,"class_iii":39,"top_root_causes":174},[],[],"6fd160c5b6cb43e7f5f26d4d63dded9f514c309944600fdeebbf16c68306cc19","2026-08-24T04:12:57.498101+00:00",{"items":179,"total":39},[],{"items":181,"total":41},[182,188,190,194,199,203,206,210,214,218,221,225],{"k_number":24,"device_name":183,"applicant":184,"decision_date":169,"clearance_type":185,"decision_code":186,"statement_or_summary":187},"INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST","Alfa Scientific Designs, Inc.","Traditional","SESE","Summary",{"k_number":27,"device_name":189,"applicant":184,"decision_date":169,"clearance_type":185,"decision_code":186,"statement_or_summary":187},"INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST",{"k_number":26,"device_name":191,"applicant":192,"decision_date":193,"clearance_type":185,"decision_code":186,"statement_or_summary":187},"LIVESURE MORPHINE SCREEN TEST","Pan Probe Biotech, Inc.","2001-04-13",{"k_number":28,"device_name":195,"applicant":196,"decision_date":197,"clearance_type":185,"decision_code":186,"statement_or_summary":198},"BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D","Branan Medical Corporation","2000-11-22","Statement",{"k_number":18,"device_name":200,"applicant":201,"decision_date":202,"clearance_type":185,"decision_code":186,"statement_or_summary":198},"ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG\u002FML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION","Roche Diagnostic Systems, Inc.","1995-06-01",{"k_number":23,"device_name":204,"applicant":201,"decision_date":205,"clearance_type":185,"decision_code":186,"statement_or_summary":198},"ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)","1994-08-09",{"k_number":25,"device_name":207,"applicant":208,"decision_date":209,"clearance_type":185,"decision_code":186,"statement_or_summary":198},"URINE HEROIN\u002FMORPHINE DIRECT RIA KIT (I-125)","Immunalysis Corporation","1994-04-06",{"k_number":20,"device_name":211,"applicant":212,"decision_date":213,"clearance_type":185,"decision_code":186,"statement_or_summary":40},"MICROMEDIC MORPHINE RIA KIT","Icn Micromedic Systems","1988-06-24",{"k_number":21,"device_name":215,"applicant":216,"decision_date":217,"clearance_type":185,"decision_code":186,"statement_or_summary":40},"THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT","Diagnostic Products Corp.","1987-03-19",{"k_number":22,"device_name":219,"applicant":201,"decision_date":220,"clearance_type":185,"decision_code":186,"statement_or_summary":40},"MORPHINE ROCHE (R) EIA TEST","1987-03-16",{"k_number":29,"device_name":222,"applicant":223,"decision_date":224,"clearance_type":185,"decision_code":186,"statement_or_summary":40},"ABUSCREEN RADIOUMMUNOASSAY--URINE","Hoffmann-La Roche, Inc.","1983-03-24",{"k_number":19,"device_name":226,"applicant":223,"decision_date":224,"clearance_type":185,"decision_code":186,"statement_or_summary":40},"ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE",{"items":228,"total":39},[]]