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FreeStyle Blood Glucose Monitoring System, FreeStyle Tracker Diabetes Management System, Models 11001, 16000, and 16005

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031260

by Abbott Diabetes Care Inc

Identifiers

510(k) Number
K031260 FDA 510(k)
FDA Product Code
NBW FDA 510(k)
Models / Variants
11001 FDA 510(k)
16000 FDA 510(k)
16005 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a blood glucose monitoring system and diabetes management system, designed for continuous or intermittent glucose level assessment. It combines a handheld meter with disposable test strips to measure capillary blood glucose levels, providing real-time results for diabetes management. The FreeStyle Tracker system further integrates data tracking and reporting for enhanced patient monitoring. Its classification aligns with clinical chemistry devices, facilitating accurate metabolic assessment.

The system is intended for use in both home and clinical settings, with models 11001, 16000, and 16005 reflecting variations in functionality or connectivity. It operates as a single-use or reusable component system, depending on the meter and accessories, though test strips are consumable. No MRI safety information is specified, and storage conditions are not detailed in the provided data. The device holds FDA clearance under 510(k) classification, with regulatory oversight by the Clinical Chemistry advisory committee.

Frequently asked questions

What is the FreeStyle Blood Glucose Monitoring System used for?

The FreeStyle Blood Glucose Monitoring System is designed for continuous or intermittent assessment of blood glucose levels. It provides real-time results to help manage diabetes effectively, making it suitable for both home and clinical settings. The system combines a handheld meter with disposable test strips to measure capillary blood glucose, ensuring accurate metabolic monitoring.

How are the FreeStyle Tracker Diabetes Management System models 11001, 16000, and 16005 different?

The FreeStyle Tracker Diabetes Management System includes variations in functionality or connectivity across models 11001, 16000, and 16005. While the exact differences in features are not detailed, these models likely cater to different user needs—such as varying levels of data tracking, reporting, or connectivity options—to enhance patient monitoring and management.

Are the test strips for the FreeStyle Blood Glucose Monitoring System single-use or reusable?

The test strips for the FreeStyle Blood Glucose Monitoring System are designed as single-use consumables. Each strip is intended for one measurement to ensure accuracy and hygiene, while the handheld meter itself can be reused across multiple testing sessions.

What regulatory approval does the FreeStyle Blood Glucose Monitoring System hold?

The FreeStyle Blood Glucose Monitoring System holds FDA clearance under the 510(k) classification, specifically for clinical chemistry devices. This clearance was granted by the FDA’s Clinical Chemistry advisory committee, confirming its substantial equivalence to a predicate device and ensuring compliance with regulatory standards for blood glucose monitoring.

How should the FreeStyle Blood Glucose Monitoring System be stored?

The provided data does not specify storage conditions for the FreeStyle Blood Glucose Monitoring System. For optimal performance and safety, it is generally recommended to follow manufacturer guidelines, which may include storing the meter and test strips in a cool, dry place away from direct sunlight and extreme temperatures. Always refer to the user manual for precise instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Abbott Diabetes Products | FreeStyle Libre CGM Systems, FreeStyle Libre | FreeStyle Abbott, Glucose Monitoring with FreeStyle Libre | FreeStyle Libre Providers, FreeStyle Libre 3 Sensor, Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc
FDA Applicant
Abbott Diabetes Care, Inc.

Sources (1)

  • FDA 510(k) K031260 24 fields · synced Oct 1, 2026