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Describes quantitative amperometric glucose oxidase assay testing, diabetes indications for persons age 4+, real-time alarms, and system communication with connected devices. Includes Rx-only special conditions such as restrictions with automated insulin dosing, vitamin C interference, removal before MRI/CT/diathermy, and limits for pregnancy, dialysis, critical illness, and age.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/510k-substantial-equivalence-determination-decision-summary-instrument-only-modification-purpose-test-type-intended-use-and-special-conditions/512954/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/510k-substantial-equivalence-determination-decision-summary-instrument-only-modification-purpose-test-type-intended-use-and-special-conditions/512954.png","ImageObject",300,407,{"name":42,"@type":43},"kopisore","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-29","2026-10-06",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",7,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the 510(k) number and applicant for this decision summary?","Question",{"text":63,"@type":64},"The 510(k) number is K210943 and the applicant is Abbott Diabetes Care Inc.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What device modifications are described for this submission?",{"text":68,"@type":64},"The submission modifies the existing device to add an Android mobile app as an alternate primary display and to add the FreeStyle Libre 2 MediRx sensor as another compatible CGM sensor.",{"name":70,"@type":61,"acceptedAnswer":71},"What are the key intended-use indications for the FreeStyle Libre 2 system?",{"text":72,"@type":64},"The system is indicated for diabetes management in persons age 4 and older, with real-time alarms capability. It is intended to replace blood glucose testing for diabetes treatment decisions unless otherwise indicated and helps detect hyperglycemia/hypoglycemia trends and patterns.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},512954,1791423187,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,109,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":107,"slug":108},40,"healthcare",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},8,"Research & Report",30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":97,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":55,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":139,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":144,"read_time":145,"preview_page_count":4},962090880963,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY  \nINSTRUMENT ONLY  \nI Background Information:  \nA 510(k) Number  \nK210943  \nB Applicant  \nAbbott Diabetes Care Inc.  \nC Proprietary and Established Names  \nFreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)  \nD Regulatory Information  \n\n| Product Code(s) | Classificatio\u003Cbr>n | Regulation Section | Panel |\n| --- | --- | --- | --- |\n| QLG | Class II | 21 CFR 862.1355-Integrated Continuous Glucose Monitoring System | CH-Clinical\u003Cbr>Chemistry |\n| NBW | Class II | 21 CFR 862.1345-Glucose test system | CH-Clinical\u003Cbr>Chemistry |\n\nII Submission/Device Overview:  \nA Purpose for Submission:  \nModification to an existing device to add the Android mobile app as an alternate primary display, and to add the FreeStyle Libre 2 MediRx sensor as another compatible continuous glucose monitoring (CGM) sensor.  \nB Type of Test:  \nQuantitative, amperometric assay (Glucose Oxidase)  \nIII Intended Use/Indications for Use:  \nA Intended Use(s):  \nSee Indications for Use below.  \nB Indication(s) for Use:  \nThe FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.  \nThe System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.  \nInterpretation of the System readings should be based on the glucose trends and several sequential readings over time.  \nThe System is also intended to autonomously communicate with digitally connected devices.  \nThe System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.  \nThe System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day) .  \nC Special Conditions for Use Statement(s):  \nRx-For Prescription Use Only  \n• The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.  \n• Taking ascorbic Acid (Vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Inaccurate sensor readings due to ascorbic acid interference may be clinical significant and result in harm if relied on to make treatement decisions. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event.  \n• The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.  \n• Do not use this system if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.  \n• Do not ignore symptoms that may be due to low or high blood glucose: if you are experiencing symptoms that are not consistent with the glucose readings, consult your health care professional.  \n• Do not use the System in people less than 4 years of age.  \n• Use your blood glucose meter to make diabetes treatment decisions when you see the\"check blood glucose\" symbol during the first 12 hours or wearing a Sensor. In addition, use your blood glucose meter to make diabetes treatment decisions, if your Sensor  \nglucose reading does not match how you feel, or if the reading does not include a number.  \n• Wash application site on the back of your upper arm using a plain soap, dry,","cbCailLCKzqraL3V","https://ap.wps.com/l/cbCailLCKzqraL3V","pdf",263457,11,"English","# Background Information\n## 510(k) Number\n## Applicant\n## Proprietary and Established Names\n## Regulatory Information\n# Submission/Device Overview\n## Purpose for Submission\n## Type of Test\n# Intended Use/Indications for Use\n## Intended Use(s)\n## Indication(s) for Use\n## Special Conditions for Use Statement(s)","[{\"question\":\"What is the 510(k) number and applicant for this decision summary?\",\"answer\":\"The 510(k) number is K210943 and the applicant is Abbott Diabetes Care Inc.\"},{\"question\":\"What device modifications are described for this submission?\",\"answer\":\"The submission modifies the existing device to add an Android mobile app as an alternate primary display and to add the FreeStyle Libre 2 MediRx sensor as another compatible CGM sensor.\"},{\"question\":\"What are the key intended-use indications for the FreeStyle Libre 2 system?\",\"answer\":\"The system is indicated for diabetes management in persons age 4 and older, with real-time alarms capability. It is intended to replace blood glucose testing for diabetes treatment decisions unless otherwise indicated and helps detect hyperglycemia/hypoglycemia trends and patterns.\"}]","510(k) Substantial Equivalence Determination Decision Summary - Instrument Only - Modification Purpose, Test Type, Intended Use, and Special Conditions | PDF",1791278172,28]