Question 1

What types of medical devices does Abbott Diabetes Care Inc manufacture?

Accepted Answer

Abbott Diabetes Care Inc specializes in devices for diabetes management, including home-use and point-of-care in vitro diagnostic (IVD) systems. These cover glucose monitoring (both blood and interstitial fluid), clinical chemistry analyte monitoring, self-care monitoring software, and related accessories like single-use blood lancing devices and reusable connection cables. Their products are designed for continuous or intermittent glucose tracking, data reporting, and integration with healthcare systems.

Question 2

Where is Abbott Diabetes Care Inc based, and how does that affect its regulatory oversight?

Accepted Answer

Abbott Diabetes Care Inc is based in the United States, which means its devices are regulated by the FDA. The company’s products fall under FDA classifications—Class I (generally low-risk), Class II (moderate risk requiring special controls), and Class III (high-risk requiring premarket approval)—reflecting the varying levels of oversight required for safety and effectiveness. This classification system ensures compliance with U.S. regulatory standards.

Question 3

Which regulatory registries list Abbott Diabetes Care Inc’s devices, and why are these important?

Accepted Answer

Abbott Diabetes Care Inc’s devices are listed in the FDA’s 510(k), PMA (Premarket Approval), and UDI (Unique Device Identification) registries. The 510(k) pathway is used for devices deemed substantially equivalent to existing approved products, while PMA is required for high-risk Class III devices. The UDI system ensures traceability and transparency in the supply chain, helping track devices from manufacturing to patient use for safety and compliance purposes.

Question 4

How are Abbott Diabetes Care Inc’s devices classified by the FDA, and what does that mean for users?

Accepted Answer

The FDA classifies Abbott Diabetes Care Inc’s devices as Class I, II, or III based on risk levels. Class I devices (e.g., some reusable cables) pose minimal risk and typically require general controls. Class II devices (e.g., glucose monitors) may need additional performance standards or post-market surveillance. Class III devices (e.g., certain advanced monitoring systems) are high-risk and require rigorous premarket approval to ensure safety and efficacy before reaching users. This classification ensures appropriate oversight tailored to the device’s risk profile.

Question 5

What kinds of software solutions does Abbott Diabetes Care Inc develop for diabetes management?

Accepted Answer

Abbott Diabetes Care Inc develops self-care monitoring and reporting software, such as applications for continuous glucose monitoring (e.g., LibreView Government) and companion apps for devices like the FreeStyle Libre 3. These tools enable users to track glucose trends, share data with healthcare providers, and automate alerts—integrating hardware and software for comprehensive diabetes management. Such solutions are regulated as medical devices when they directly influence clinical decisions or patient care.

Device	Model / Reference	Registries	Class	Status
FreeStyle Libre 2 System, FreeStyle Libre 3 System	K223537	FDA 510(k)	Class II	Active
Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23	K092638	FDA 510(k)	Class II	Active
Freestyle Aviator Insulin Delivery And Blood Glucose Monitoring System	K083225	FDA 510(k)	Class II	Active
Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count): 70973-01	K083223	FDA 510(k)	Class II	Active
Connect Data Management System	K994433	FDA 510(k)	Class II	Active
Libre Rio Continuous Glucose Monitoring System	K233861	FDA 510(k)	Class II	Active
Insulin Pump	K051041	FDA 510(k)	Class II	Active
Freestyle 600 Blood Glucose Monitoring System	K050500	FDA 510(k)	Class II	Active
Freestyle Tracker Diabetes Management System	K020866	FDA 510(k)	Class II	Active
FreeStyle Precision Neo Blood Glucose Monitoring System	K142928	FDA 510(k)	Class II	Active
Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, And 16005	K031260	FDA 510(k)	Class II	Active
Freestyle Lite Blood Glucose Monitoring System	K070850	FDA 510(k)	Class II	Active
Precision Xceed Pro Blood Glucose And B-Ketone Monitoring System With Models Bgms:70900-03, 70090-02, G3ch Strips	K080960	FDA 510(k)	Class II	Active
Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50ct), Test Strips (100ct)	K140371	FDA 510(k)	Class II	Active
Relion Ultima Advance Blood Glucose Monitoring System Models, Bgms 71030-01 Strips: 7103-01 (20 Count)	K081975	FDA 510(k)	Class II	Active
Modification To Blood Glucose Monitoring System	K012014	FDA 510(k)	Class II	Active
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring System	K092602	FDA 510(k)	Class II	Active
Freestyle Blood Glucose Monitoring System	K992684	FDA 510(k)	Class II	Active
Freestyle Insulinx Blood Glucose Monitoring System	K120568	FDA 510(k)	Class II	Active
Copilot Health Management System	K062770	FDA 510(k)	Class II	Active
Aviator Insulin Pump	K071788	FDA 510(k)	Class II	Active
The Precision / Optium Point Of Care Blood Glucose Test Strips	K070984	FDA 510(k)	Class II	Active
Freestyle Precision Pro Blood Glucose And B-Ketone Monitoring System	K132511	FDA 510(k)	Class II	Active
FreeStyle Precision Neo H Blood Glucose Monitoring System	K153330	FDA 510(k)	Class II	Active
Freestyle Precision Pro Blood Glucose And B-Ketone Monitoring System	K130094	FDA 510(k)	Class II	Active
Free-Style Freedom Blood Glucose Monitoring System, Model 11001	K051839	FDA 510(k)	Class II	Active
Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips	K060768	FDA 510(k)	Class I	Active
Freestyle Connect Blood Glucose Monitoring System	K051802	FDA 510(k)	Class II	Active
FreeStyle Precision Neo Blood Glucose Test Strips	K171941	FDA 510(k)	Class II	Active
Freestyle Libre Flash Glucose Monitoring System	P160030	FDA PMA	Class III	Active
FreeStyle Libre Pro Flash Glucose Monitoring System	P150021	FDA PMA	Class III	Active

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