[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OJQ":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":114,"syncDates":115,"translation":122,"marketSummary":129,"recalls":143,"k510s":145,"pmas":159},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},4858,"OJQ","Cardiac Allograft Gene Expression Profiling Test System","2","862.1163","CV","Cardiovascular","CH","1","In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate\u002Fsevere acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":24,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":12,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":24,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":18,"fei_number":21,"registration_number":23},[19,20],"DEN080007","K221640",[22],"3005225997",[22],"","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:47.949024+00:00",0,null,2,[],[34,43,51,59,68,76,84,92,99,107],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},1157,"遺伝子変異解析システム（がんゲノムプロファイリング検査用）","Ⅲ","60943033",0.290698,0.202353,0.646209,0.0322665,{"medical_device_id":44,"generic_name":45,"class_classification":37,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},1147,"遺伝子変異解析セット（がんゲノムプロファイリング検査用）","60943013",0.213483,0.184615,0.648003,0.0304147,{"medical_device_id":52,"generic_name":53,"class_classification":37,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1151,"遺伝子変異解析プログラム（がんゲノムプロファイリング検査用）","60943023",0.202128,0.193627,0.631955,0.0288501,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},3169,"ICG検査用画像解析プログラム","Ⅱ","71047002",0.108696,0.209957,0.658809,0.0163934,{"medical_device_id":69,"generic_name":70,"class_classification":62,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},1440,"心臓運動負荷モニタリングシステム","36145000",0.276316,0.256198,0.519594,0.016129,{"medical_device_id":77,"generic_name":78,"class_classification":62,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},1483,"心臓画像処理装置","70069000",0.274194,0.160494,0.593373,0.015873,{"medical_device_id":85,"generic_name":86,"class_classification":37,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},1165,"体細胞遺伝子変異解析セット（抗悪性腫瘍薬適応判定用）","71059023",0.0944882,0.226601,0.644504,0.015625,{"medical_device_id":93,"generic_name":94,"class_classification":62,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":91},2994,"心臓マッピングシステムワークステーション","31742002",0.25,0.186047,0.531874,{"medical_device_id":100,"generic_name":101,"class_classification":37,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},340,"不整脈モニタリングシステム","43239000",0.24,0.235955,0.53987,0.0153846,{"medical_device_id":108,"generic_name":109,"class_classification":37,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":106},1140,"体細胞遺伝子変異解析システム（抗悪性腫瘍薬適応判定用）","71059003",0.145161,0.238532,0.637264,[],{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"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":123,"definition_ja":124,"commentary_ja":125,"model_name":126,"source_hash":127,"reviewed_by":30,"reviewed_at":30,"created_at":128,"updated_at":128},"心臓同種移植片遺伝子発現プロファイリング検査システム","末梢血単核球（PBMC）から単離したRNAの遺伝子発現プロファイルを評価するための、単一の検査施設で実施されるインビトロ診断用多変量指数アッセイ（IVDMIA）検査サービスであって、標準的な臨床評価と併用して、検査時点で中等度／重度の急性細胞性拒絶反応（ACR）の可能性が低い、同種移植片機能が安定した心臓移植レシピエントの識別を補助する目的で使用されることが意図されているものをいう。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象として、既存の同等な機器との実質的同等性を示すことで市販が認められる審査区分に位置づけられています。クラスIIはクラスIIIに比べてリスクが中程度とされる機器区分であり、性能に関する特別管理により安全性・有効性が確保されると考えられているものです。","claude-sonnet-5","bdf829c86d4e0b45872a2405dbdc1bf27a6cf9fbf33501c07e4cc40e12311404","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":130,"stats":131,"stats_hash":141,"model_name":126,"created_at":142,"updated_at":142},"510(k)の累計届出件数は2件で、参入企業数は2社、直近5年では1件の届出が確認されています。不具合報告および回収については、いずれも累計0件であり、確認されていません。",{"pma":132,"k510":133,"as_of":136,"events":137,"recalls":138,"top_problems":140},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":134,"latest":135,"applicants":31},1,"2023-09-13","2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":139},[],[],"d79c9e57befaf73a4b4dd67d6a2ffeea59ba25b2d842eb2ee50d97633de31b59","2026-08-24T05:03:24.690751+00:00",{"items":144,"total":29},[],{"items":146,"total":31},[147,153],{"k_number":20,"device_name":148,"applicant":149,"decision_date":135,"clearance_type":150,"decision_code":151,"statement_or_summary":152},"AlloMap Heart Molecular Expression Testing","Caredx, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":154,"applicant":155,"decision_date":156,"clearance_type":157,"decision_code":158,"statement_or_summary":30},"ALLOMAP MOLECULAR EXPRESSION TESTING","Xdx","2008-08-26","Post-NSE","DENG",{"items":160,"total":29},[]]