[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SEI":3},{"classification":4,"mappedDevices":89,"similarCandidates":90,"relatedClassifications":171,"syncDates":172,"translation":179,"marketSummary":186,"recalls":204,"k510s":206,"pmas":223},{"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":83,"updated_at":84,"recall_count":85,"latest_recall_date":86,"k510_count":87,"pma_count":88,"event_count":87},2078,"SEI","Qualitative And Quantitative Hepatitis B Virus Antibody Assays","2","866.3173","MI","Microbiology","1","In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is 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vitro診断用医療機器である。これらの機器は、肝炎の徴候および症状を有する者ならびにHBV感染のリスクを有する者におけるHBV感染の診断の補助を目的とする。抗HBs抗体検査の結果は、HBVワクチン接種前もしくは接種後、またはワクチン接種歴が不明な場合における個人のHBV感染に対する感受性の判定の補助として使用され得る。","米国ではクラスIIに分類されており、市販前届出（510(k)）による審査区分の対象となっています。これは、既に市販されている同等の機器（既存機器）との実質的同等性を示すことで承認が得られる区分であり、クラスIIIに適用される市販前承認（PMA）よりも簡略化された審査プロセスです。","claude-sonnet-5","edfe537d219757954e52a4c65b834f836239de553f256c69f1ba03a255f1f9ee","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":187,"stats":188,"stats_hash":202,"model_name":183,"created_at":203,"updated_at":203},"本製品は510(k)累計4件（参入企業2社、直近5年で4件）に加え、PMAでも本承認30件の実績があります。不具合報告は累計約4件で、死亡・傷害の報告はなく、すべてMalfunction（不具合）に分類されており、主な問題としてFalse Negative Result（偽陰性）およびFalse Positive Result（偽陽性）が挙げられています。回収については累計0件で、これまでのところ確認されていません。",{"pma":189,"k510":191,"as_of":194,"events":195,"recalls":197,"top_problems":199},{"latest":190,"originals":88,"supplements":85},"2022-07-27",{"total":87,"last5y":87,"latest":192,"applicants":193},"2026-04-07",2,"2026-08",{"death":85,"other":85,"total":87,"injury":85,"last5y":87,"malfunction":87,"latest_month":196},"2026-07",{"total":85,"last5y":85,"latest":86,"class_i":85,"class_ii":85,"class_iii":85,"top_root_causes":198},[],[200,201],"False Negative Result","False Positive Result","c90628c36b8655fa5605ee1228fd6a791581842a202b0ba5b225a3985f0bb79d","2026-08-24T05:23:16.025025+00:00",{"items":205,"total":85},[],{"items":207,"total":87},[208,214,216,220],{"k_number":18,"device_name":209,"applicant":210,"decision_date":192,"clearance_type":211,"decision_code":212,"statement_or_summary":213},"Elecsys Anti-HBc IgM","Roche Diagnostics","Traditional","SESE","Summary",{"k_number":21,"device_name":215,"applicant":210,"decision_date":192,"clearance_type":211,"decision_code":212,"statement_or_summary":213},"Elecsys Anti-HBc II",{"k_number":19,"device_name":217,"applicant":218,"decision_date":219,"clearance_type":211,"decision_code":212,"statement_or_summary":213},"Access anti-HBc IgM","Beckman Coulter, Inc.","2026-03-13",{"k_number":20,"device_name":221,"applicant":218,"decision_date":222,"clearance_type":211,"decision_code":212,"statement_or_summary":213},"Access anti-HBc Total","2026-02-19",{"items":224,"total":88},[225,228,231,234,237,241,243,246,249,252,256,259,261,265,268,271,275,278,282,285],{"pma_number":54,"supplement_number":80,"trade_name":226,"applicant":227,"decision_date":190},"ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)","Siemens Healthcare Diagnostics, Inc.",{"pma_number":60,"supplement_number":80,"trade_name":229,"applicant":227,"decision_date":230},"ADVIA Centaur Anti-HBe2 (aHBe2) assay","2021-07-14",{"pma_number":45,"supplement_number":80,"trade_name":232,"applicant":210,"decision_date":233},"Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck","2021-02-23",{"pma_number":50,"supplement_number":80,"trade_name":235,"applicant":210,"decision_date":236},"Elecsys Anti-HBe, PreciControl Anti-HBe","2021-02-03",{"pma_number":56,"supplement_number":80,"trade_name":238,"applicant":239,"decision_date":240},"LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe","DiaSorin, Inc.","2020-08-29",{"pma_number":68,"supplement_number":80,"trade_name":242,"applicant":239,"decision_date":240},"LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM",{"pma_number":66,"supplement_number":80,"trade_name":244,"applicant":239,"decision_date":245},"LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers","2020-02-21",{"pma_number":55,"supplement_number":80,"trade_name":247,"applicant":239,"decision_date":248},"LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc","2020-01-02",{"pma_number":67,"supplement_number":80,"trade_name":250,"applicant":227,"decision_date":251},"ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL","2012-01-20",{"pma_number":69,"supplement_number":80,"trade_name":253,"applicant":254,"decision_date":255},"ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM","Roche Diagnostics Corp.","2012-01-03",{"pma_number":58,"supplement_number":80,"trade_name":257,"applicant":254,"decision_date":258},"ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA","2011-12-14",{"pma_number":46,"supplement_number":80,"trade_name":253,"applicant":254,"decision_date":260},"2011-10-26",{"pma_number":43,"supplement_number":80,"trade_name":262,"applicant":263,"decision_date":264},"VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK\u002FANTI-HBE CALIBRATOR\u002FANTI HBE CONTROLS","Ortho-Clinical Diagnostics","2011-07-20",{"pma_number":49,"supplement_number":80,"trade_name":266,"applicant":254,"decision_date":267},"ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER","2011-06-27",{"pma_number":57,"supplement_number":80,"trade_name":269,"applicant":254,"decision_date":270},"ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC","2011-06-22",{"pma_number":53,"supplement_number":80,"trade_name":272,"applicant":273,"decision_date":274},"ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS","Abbott Laboratories","2009-04-10",{"pma_number":47,"supplement_number":80,"trade_name":276,"applicant":273,"decision_date":277},"ARCHITECT CORE-M REAGENT KIT\u002FCALIBRATORS\u002FCONTROLS","2007-11-06",{"pma_number":51,"supplement_number":80,"trade_name":279,"applicant":280,"decision_date":281},"BIO RAD MONOLISA ANTI-HBC IGM EIA","Bio-Rad Laboratories, Inc.","2007-05-31",{"pma_number":52,"supplement_number":80,"trade_name":283,"applicant":280,"decision_date":284},"BIO-RAD MONOLISA ANTI-HBC EIA","2007-04-27",{"pma_number":71,"supplement_number":80,"trade_name":286,"applicant":287,"decision_date":288},"MONOLISA ANTI-HBS EIA","Bio-Rad Laboratories","2006-08-25"]