[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QLC":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":112,"syncDates":113,"translation":120,"marketSummary":127,"recalls":146,"k510s":148,"pmas":150},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":31,"pma_count":31,"event_count":33},5889,"QLC","Interleukin 6","N","","Unknown","IM","8","In vitro Diagnostic devices for the quantitative determination of IL-6 (interleukin 6) in human specimens",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":8,"product_code":6,"review_panel":11,"gmp_exempt_flag":8,"third_party_flag":8,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":8,"medical_specialty_description":10,"summary_malfunction_reporting":28},{"fei_number":17,"registration_number":23},[18,19,20,21,22],"3002808140","2432235","1000136573","2020726","3002806559",[24,25,19,26,21],"8032314","9610126","1319681","11","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:47.949024+00:00",0,null,39,[],[36,45,53,61,68,75,82,90,97,105],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},2360,"腸管用バッグ","Ⅱ","33522000",0.166667,0.0783133,0.457785,0.0163934,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":44},3514,"粒子計測免疫測定装置","Ⅰ","70181000",0.0192308,0.152047,0.675254,{"medical_device_id":54,"generic_name":55,"class_classification":39,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},1920,"腸管用チューブ","35415020",0.153846,0.147783,0.448178,0.016129,{"medical_device_id":62,"generic_name":63,"class_classification":48,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":60},3509,"移動式免疫比濁分析装置","35926020",0.0204082,0.136364,0.650858,{"medical_device_id":69,"generic_name":70,"class_classification":39,"jmdn_code":71,"name_similarity":66,"definition_similarity":72,"vector_similarity":73,"score":74},2030,"イントロデューサ","12727010",0.259542,0.475133,0.015873,{"medical_device_id":76,"generic_name":77,"class_classification":48,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":74},3511,"移動式免疫蛍光分析装置","35707020",0.0212766,0.128514,0.64738,{"medical_device_id":83,"generic_name":84,"class_classification":39,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},1367,"皮膚赤外線体温計","17888000",0.142857,0.189873,0.526139,0.015625,{"medical_device_id":91,"generic_name":92,"class_classification":48,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":89},3508,"免疫比濁分析装置","35926010",0.0238095,0.134328,0.639043,{"medical_device_id":98,"generic_name":99,"class_classification":39,"jmdn_code":100,"name_similarity":101,"definition_similarity":102,"vector_similarity":103,"score":104},1596,"眼科用干渉縞視力測定器","36397000",0.147059,0.158416,0.541297,0.0153846,{"medical_device_id":106,"generic_name":107,"class_classification":48,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":104},3506,"移動式酵素免疫測定装置","35706020",0.0208333,0.146341,0.636052,[],{"510k":114,"classification":115,"enforcement":116,"event":117,"pma":118,"warning_letter":119},"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":121,"definition_ja":122,"commentary_ja":123,"model_name":124,"source_hash":125,"reviewed_by":32,"reviewed_at":32,"created_at":126,"updated_at":126},"インターロイキン6測定用体外診断薬","ヒト検体中のIL-6（インターロイキン6）を定量するための体外診断用機器である。","本品は米国においてデバイスクラスが「分類対象外」とされており、通常の510(k)やPMAといった市販前審査の枠組みではなく、EUA（緊急使用許可）に基づいて使用が認められている点が特徴です。EUAは公衆衛生上の緊急事態に対応するため、通常の審査手続きを経ずに一時的に機器の使用を許可する制度であり、恒久的な市販承認とは異なる位置づけとなります。","claude-sonnet-5","3cfbd72ba48323ab282e78fb5d7b47fdaadd9dc3a53d64c51a1cde3cb66b80cb","2026-08-24T02:37:21.239845+00:00",{"product_code":6,"summary_ja":128,"stats":129,"stats_hash":144,"model_name":124,"created_at":145,"updated_at":145},"QLCは分類対象外の体外診断用機器で、EUA（緊急使用許可）の枠組みで審査されており、510(k)およびPMAの承認実績は確認されていません。不具合報告は累計約40件で、直近5年間では約30件が報告されており、大半が不具合（Malfunction）で、傷害が1件、死亡は報告されていません。主な問題としてはHigh Test Results（高値結果）、Imprecise or Erratic Results（不正確・不安定な結果）、Low Test Results（低値結果）が挙げられています。回収については累計0件で、クラスI〜IIIいずれも確認されていません。",{"pma":130,"k510":131,"as_of":132,"events":133,"recalls":138,"top_problems":140},{"latest":32,"originals":31,"supplements":31},{"total":31,"last5y":31,"latest":32,"applicants":31},"2026-08",{"death":31,"other":31,"total":33,"injury":134,"last5y":135,"malfunction":136,"latest_month":137},1,28,38,"2026-04",{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":139},[],[141,142,143],"High Test Results","Imprecise or Erratic Results","Low Test Results","6bc93cdb03d162fbbbb8ab2e4afb6daaa128454ce715df4193335527a70ef478","2026-08-24T05:19:21.416523+00:00",{"items":147,"total":31},[],{"items":149,"total":31},[],{"items":151,"total":31},[]]