FreeStyle Precision Neo H Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153330 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 H Blood Glucose Monitoring System is a blood glucose meter designed for self-monitoring of blood glucose levels in diabetic patients. It falls under the category of in vitro diagnostic devices for clinical chemistry, providing accurate glucose readings from a small blood sample. The system includes a meter, test strips, and lancets to facilitate convenient and reliable monitoring at home or in clinical settings. Its design supports rapid results and trend analysis to help manage diabetes effectively.
This system is supplied as a reusable device with single-use test strips and lancets. It is intended for use in non-sterile environments, such as home or clinical settings, and does not require sterilisation. The device is FDA-cleared under the 510(k) pathway, with a clearance date of February 19, 2016, and is classified under product code NBW. Storage instructions and MRI safety information are not specified in the provided data, but the device is intended for prescription use only.
Frequently asked questions
What is the FreeStyle Precision Neo H Blood Glucose Monitoring System used for?
This system is designed for self-monitoring of blood glucose levels in diabetic patients. It provides accurate readings from a small blood sample, helping users track glucose trends to better manage their diabetes. The device is suitable for both home and clinical use, offering convenience and reliability for regular monitoring.
How is the FreeStyle Precision Neo H Blood Glucose Monitoring System supplied?
The system includes a reusable meter, single-use test strips, and single-use lancets. This setup ensures hygiene and convenience, as the meter itself is not disposable, while the consumables (strips and lancets) are intended for one-time use only.
Is the FreeStyle Precision Neo H Blood Glucose Monitoring System sterile?
No, the device is not sterile. It is intended for use in non-sterile environments like homes or clinical settings where sterilization is unnecessary. The single-use test strips and lancets help maintain cleanliness for each test.
Is the FreeStyle Precision Neo H Blood Glucose Monitoring System single-use or reusable?
The meter itself is reusable, while the test strips and lancets are designed for single-use only. This design balances durability with hygiene, allowing users to reuse the meter over time while ensuring each test uses fresh, dedicated consumables.
What regulatory pathway does the FreeStyle Precision Neo H Blood Glucose Monitoring System follow?
The device is FDA-cleared under the 510(k) pathway, specifically classified as substantially equivalent to a predicate device. It was cleared on February 19, 2016, under product code NBW, which categorizes it as an in vitro diagnostic device for clinical chemistry.
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, ABBOTT FREESTYLE PRECISION NEO USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153330 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K153330 24 fields · synced Oct 5, 2026