[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PQW":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":118,"syncDates":134,"translation":141,"marketSummary":148,"recalls":161,"k510s":163,"pmas":181},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":33},6557,"PQW","Alpha-D-Galactosidase A (Gla) Newborn Screening Test System","2","862.1488","CH","Clinical Chemistry","1","For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":21,"registration_number":25},[18,19,20],"K190266","K173829","DEN150035",[22,23,24],"3011240982","3002808498","3042250641",[22,24,26],"8043909","","N","Y","Ineligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:47.808424+00:00",0,null,3,[],[38,47,56,64,73,80,88,95,103,110],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},3572,"自動尿スクリーニングシステム","Ⅰ","30648000",0.242857,0.0718232,0.649129,0.030478,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},1166,"マラリア診断装置","Ⅲ","71081003",0.125,0.126582,0.64356,0.0246246,{"medical_device_id":57,"generic_name":58,"class_classification":41,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},3511,"移動式免疫蛍光分析装置","35707020",0.0113636,0.162055,0.687189,0.0163934,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},1248,"胸部集団検診用X線診断装置","Ⅱ","37627010",0.197802,0.0890869,0.621051,0.016129,{"medical_device_id":74,"generic_name":75,"class_classification":41,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":72},3510,"免疫蛍光分析装置","35707010",0.0123457,0.158915,0.684289,{"medical_device_id":81,"generic_name":82,"class_classification":67,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},1246,"腹部集団検診用X線診断装置","37675010",0.193548,0.0942529,0.626507,0.015873,{"medical_device_id":89,"generic_name":90,"class_classification":41,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":87},3555,"ラジオイムノアッセイ用装置","35506000",0.0125,0.128049,0.673008,{"medical_device_id":96,"generic_name":97,"class_classification":67,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},1808,"健康検診システム","70178000",0.186667,0.138528,0.623543,0.015625,{"medical_device_id":104,"generic_name":105,"class_classification":41,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":102},3506,"移動式酵素免疫測定装置","35706020",0.011236,0.122172,0.668052,{"medical_device_id":111,"generic_name":112,"class_classification":67,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},1252,"歯科集団検診用パノラマX線撮影装置","70002000",0.191011,0.099359,0.556591,0.0153846,[119,122,125,128,131],{"product_code":120,"device_name":121,"device_class":8,"k510_count":33},"PQT","Alpha-L-Iduronidase (Idua) Newborn Screening Test System",{"product_code":123,"device_name":124,"device_class":8,"k510_count":33},"PQU","Alpha-D-Glucosidase (Gaa) Newborn Screening Test System",{"product_code":126,"device_name":127,"device_class":8,"k510_count":33},"PQV","ß-Glucocerebrosidase (Gba) Newborn Screening Test System",{"product_code":129,"device_name":130,"device_class":8,"k510_count":33},"QCL","Acid-Sphingomyelinase (Asm) Newborn Screening Test System",{"product_code":132,"device_name":133,"device_class":8,"k510_count":33},"QCM","ß-Galactocerebrosidase (Galc) Newborn Screening Test System",{"510k":135,"classification":136,"enforcement":137,"event":138,"pma":139,"warning_letter":140},"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":142,"definition_ja":143,"commentary_ja":144,"model_name":145,"source_hash":146,"reviewed_by":34,"reviewed_at":34,"created_at":147,"updated_at":147},"α-D-ガラクトシダーゼA新生児スクリーニング検査システム","新生児の乾燥血液スポット検体からのα-D-ガラクトシダーゼA（GLA）の活性の定量測定のためのものである。","この機器は米国の医療機器規制においてクラスIIに分類されており、市販前届出（510(k)）による審査区分が適用されます。510(k)は、既存の合法的に販売されている類似機器（プレディケート）と実質的に同等であることを示すことで市販が認められる区分であり、クラスIIIの機器に適用される市販前承認（PMA）に比べて簡便な審査プロセスとなっています。","claude-sonnet-5","3a37fc0b2bd967cb41ebb074895cd7aab7e25151dec41f465fa80fbb54fb84e3","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":149,"stats":150,"stats_hash":159,"model_name":145,"created_at":160,"updated_at":160},"510(k)の累計件数は3件で、参入企業数は3社となっていますが、直近5年間の届出はなく、最新の判定は2019年5月です。不具合報告および回収については、いずれも累計件数が0件で、確認されていません。",{"pma":151,"k510":152,"as_of":154,"events":155,"recalls":156,"top_problems":158},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":153,"applicants":35},"2019-05-03","2026-08",{"death":33,"other":33,"total":33,"injury":33,"last5y":33,"malfunction":33,"latest_month":34},{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":157},[],[],"eecb5f7c4fa39b5cdd2db2d918efe5a5355d4e827be2498c449e190164fa3a17","2026-08-24T05:13:39.867404+00:00",{"items":162,"total":33},[],{"items":164,"total":35},[165,171,175],{"k_number":18,"device_name":166,"applicant":167,"decision_date":153,"clearance_type":168,"decision_code":169,"statement_or_summary":170},"NeoLSD MSMS Kit","Perkinelmer, Inc.","Traditional","SESE","Summary",{"k_number":19,"device_name":172,"applicant":173,"decision_date":174,"clearance_type":168,"decision_code":169,"statement_or_summary":170},"NeoLSD MSMS kit","Wallac Oy, A Subsidiary of Perkinelmer","2018-07-18",{"k_number":20,"device_name":176,"applicant":177,"decision_date":178,"clearance_type":179,"decision_code":180,"statement_or_summary":34},"SEEKER System","Baebies, Inc.","2017-02-03","Direct","DENG",{"items":182,"total":33},[]]