[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PVF":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":42,"syncDates":47,"translation":54,"marketSummary":61,"recalls":75,"k510s":77,"pmas":79},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":37,"pma_count":37,"event_count":39},4241,"PVF","Test, Methaqualone, Employment And Insurance Testing, Exempt","2","862.3630","TX","Clinical Toxicology","4","The methaqualone test is an in vitro diagnostic test for the qualitative analysis of methaqualone for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976).  Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register  (82 FR 31976) available at https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce.  If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":18,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":18,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"fei_number":17,"registration_number":32},[18,19,20,21,22,23,24,25,26,27,28,29,30,31],"","3008517993","3006048451","3030648160","3009585529","3043127647","3012073813","3021986677","3017060097","3021010433","3010934853","3009238284","3032147516","3027519599",[18,19,20,21,22,23,24,25,26,27,28,29,30,31],"N","Ineligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:48.620842+00:00",0,null,1,[],[],[43],{"product_code":44,"device_name":45,"device_class":8,"k510_count":46},"KXS","Radioimmunoassay, Methaqualone",16,{"510k":48,"classification":49,"enforcement":50,"event":51,"pma":52,"warning_letter":53},"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":55,"definition_ja":56,"commentary_ja":57,"model_name":58,"source_hash":59,"reviewed_by":38,"reviewed_at":38,"created_at":60,"updated_at":60},"メタクアロン検査キット（雇用及び保険検査用）","メタクアロン検査は、雇用及び保険検査のためのメタクアロンの定性分析を目的とした体外診断用検査である。FDAは、2017年7月11日付連邦官報（82 FR 31976、https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices で入手可能）を公布することにより、これらの機器を市販前届出要件から免除した。ただし、21 CFR XXX.9（XXXはパート862から892を指す）に基づく制限、及び（82 FR 31976）に記載された当該免除に関するその他の制限に従うものとする。21 CFRセクション862.9から892.9に定める制限、又は連邦官報（82 FR 31976、https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices で入手可能）に示された制限を超える機器については、州際通商への導入前にFDAへの市販前届出（510(k)）の提出が必要である。製造業者の機器が市販前届出要件を免除されている場合、米国内での販売前に市販前届出の提出及びFDAのクリアランスは不要であるが、製造業者は登録及びリスティング要件を含む（ただしこれらに限定されない）連邦食品・医薬品・化粧品法及びその施行規則に基づく他のすべての要件を満たすことが求められる。登録及びリスティングに関する追加情報については、Device Registration and Listingのウェブサイトを参照されたい。","この機器は米国においてクラスIIに分類されていますが、市販前届出（510(k)）の要件が免除されている点が特徴です。通常クラスIIの医療機器は510(k)による市販前届出とFDAのクリアランス取得が求められますが、本機器のように届出免除とされた品目については、州際通商へ導入する前に510(k)を提出する必要はありません。ただし、届出が免除されていても、登録及びリスティングなど連邦食品・医薬品・化粧品法に基づく他の規制要件は引き続き適用されます。","claude-sonnet-5","3cb2ec19d2b8f29f2a6bd45f7c9cdf82b962b8a2030937020828e8fc8d3891cc","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":62,"stats":63,"stats_hash":73,"model_name":58,"created_at":74,"updated_at":74},"本製品コードは届出免除の区分であり、510(k)およびPMAの実績は確認されていません。不具合報告は累計約1件で、死亡・傷害の報告はなく、Malfunction（不具合）として計上されています。主な問題としてはActivation Failure（作動不良）が報告されており、最新の報告月は2025年10月です。回収については累計件数がなく、確認されていません。",{"pma":64,"k510":65,"as_of":66,"events":67,"recalls":69,"top_problems":71},{"latest":38,"originals":37,"supplements":37},{"total":37,"last5y":37,"latest":38,"applicants":37},"2026-08",{"death":37,"other":37,"total":39,"injury":37,"last5y":39,"malfunction":39,"latest_month":68},"2025-10",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":70},[],[72],"Activation Failure","91e999e1a66e2efbf7676396524f91be0dad29b2622aabd926e5052d89bb0ada","2026-08-24T05:15:00.389328+00:00",{"items":76,"total":37},[],{"items":78,"total":37},[],{"items":80,"total":37},[]]