FreeStyle Precision Neo Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142928 FDA 510(k)
- FDA Product Code
- NBW 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)
The FreeStyle Precision Neo Blood Glucose Monitoring System is a blood glucose meter classified as an in vitro diagnostic device for self-monitoring of blood glucose levels. It provides quantitative results to assist individuals in managing diabetes by measuring glucose concentrations in capillary whole blood samples. The device includes trend indicators to help identify patterns of high or low blood glucose levels, aiding in treatment decisions. Its design aligns with regulatory definitions for portable, single-patient-use glucose monitoring systems.
This system is intended for use outside the body and is supplied as a single-use device, requiring no sterilization or reprocessing. It operates independently of MRI environments and is not intended for hospital or clinical laboratory settings. The device is authorized under FDA 510(k) clearance (K142928) as substantially equivalent to a predicate device, with review by the Clinical Chemistry Advisory Committee. Storage and handling follow standard in vitro diagnostic device protocols, as outlined in the manufacturer’s instructions.
Frequently asked questions
What is the FreeStyle Precision Neo Blood Glucose Monitoring System used for?
This system is designed for self-monitoring of blood glucose levels in individuals managing diabetes. It measures glucose concentrations in capillary whole blood samples to provide quantitative results, helping users track trends and make informed treatment decisions. The device is not intended for hospital or clinical laboratory use but is specifically engineered for portable, at-home monitoring.
Is the FreeStyle Precision Neo Blood Glucose Monitoring System single-use or reusable?
The FreeStyle Precision Neo is a single-use device. Each unit is intended for one patient and does not require sterilization or reprocessing. This design ensures hygiene and eliminates the need for cleaning or maintenance between uses.
Does this device require special storage or handling?
Storage and handling follow standard protocols for in vitro diagnostic devices, as outlined in the manufacturer’s instructions. The device should be stored and used according to the provided guidelines to maintain accuracy and reliability. No additional sterilization or environmental controls (like MRI compatibility) are required for its operation.
Can this glucose monitor be used in environments with MRI machines?
No, the FreeStyle Precision Neo is not intended for use in MRI environments. Its design is optimized for portable, at-home monitoring and does not include features or materials compatible with magnetic resonance imaging settings.
What regulatory approval does this device hold?
The FreeStyle Precision Neo Blood Glucose Monitoring System holds FDA 510(k) clearance under the classification K142928. It was reviewed by the Clinical Chemistry Advisory Committee and deemed substantially equivalent to a predicate device through a special review process. This approval confirms its compliance with U.S. regulatory standards for in vitro diagnostic devices.
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: FreeStyle Precision Neo Blood Glucose Monitoring System / 7517583, Blood Glucose Monitor User Manuals - diabetescare.abbott, FreeStyle Libre | FreeStyle Abbott, FreeStyle Libre 3 Sensor, PDF Abbott Freestyle Precision Neo User Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142928 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K142928 24 fields · synced Oct 6, 2026