Freestyle Precision Pro Blood Glucose And B-Ketone Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132511 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 Pro Blood Glucose and β-Ketone Monitoring System is a point-of-care diagnostic device classified as an in vitro diagnostic reagent system for quantitative measurement. It is designed to detect glucose (D-glucose) and ketone bodies (β-hydroxybutyrate) in fresh capillary whole blood samples obtained from fingertip punctures. This system combines blood glucose and ketone monitoring in a single platform, supporting clinical management of metabolic conditions. Its intended use aligns with regulatory definitions for diagnostic reagent systems under the Clinical Chemistry category.
This system is intended for hospital and clinical laboratory use, providing results for immediate patient care decisions. It is supplied as a single-use device, requiring no sterilization beyond manufacturer-provided packaging. The system operates outside MRI environments and includes a meter (model-specific) paired with test strips for glucose and ketone assays. Authorized under FDA 510(k) clearance (K132511) as substantially equivalent, it adheres to regulatory standards for in vitro diagnostics, ensuring compliance with Clinical Chemistry advisory committee guidelines.
Frequently asked questions
What conditions is the FreeStyle Precision Pro designed to support?
This system is intended for clinical management of metabolic conditions by simultaneously measuring glucose (D-glucose) and ketone bodies (β-hydroxybutyrate) in fresh capillary whole blood. The combined results assist healthcare providers in making immediate patient care decisions, particularly for conditions like diabetic ketoacidosis or metabolic disorders requiring both glucose and ketone monitoring.
How is the FreeStyle Precision Pro supplied, and what does a typical use require?
The system is supplied as a single-use device, meaning each test strip is intended for one measurement. No additional sterilization is required beyond the manufacturer-provided packaging. Use involves obtaining a capillary blood sample from a fingertip puncture, applying it to a test strip, and inserting the strip into the paired meter (model-specific) for glucose and ketone assays.
Is the meter compatible with MRI environments?
No, the FreeStyle Precision Pro meter is not designed for use within MRI environments. Patients or staff using this system should ensure it is placed outside MRI areas to avoid interference or safety risks.
What regulatory pathway does this device follow?
The FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System is authorized under the FDA 510(k) clearance process, specifically classified as substantially equivalent (K132511) under the Clinical Chemistry category. This pathway ensures compliance with regulatory standards for in vitro diagnostics, including adherence to guidelines from the Clinical Chemistry advisory committee.
Are there different models or sizes available for this system?
The system consists of a dedicated meter paired with single-use test strips for glucose and ketone assays. While the meter is model-specific, the test strips are standardized for this system and not interchangeable with other glucose or ketone monitors. No additional sizes or models are referenced in the specifications.
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 Pro | Healthcare Professionals | Abbott, Abbott FreeStyle Precision Pro Operator's Manual, FreeStyle Libre | FreeStyle Abbott, PDF Blood Glucose and β-Ketone Monitoring Meter Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132511 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA 510(k) K132511 24 fields · synced Oct 5, 2026