Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001
by Abbott Laboratories 510(k)
Active
510(k) K123089
Overview
Freestyle Auto-Assist Software Version 2.0 (Model PRT24238-001) is a clinical chemistry software application designed to assist individuals with diabetes in reviewing, analyzing, and evaluating glucose monitoring data. It facilitates the interpretation of continuous glucose monitoring (CGM) or meter-based readings to support diabetes management decisions.
The software is intended for use with compatible Abbott diabetes care meters and is supplied as a standalone digital application. It operates under a FDA 510(k) clearance (K123089) as substantially equivalent to a predicate device, with no explicit sterility or single-use/reusable designation. No MRI safety or size specifications are provided in the regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123089 | Date5 Apr 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the Freestyle Auto-Assist Software Version 2.0, and how does it help users manage their diabetes?
The Freestyle Auto-Assist Software Version 2.0 is designed to assist individuals with diabetes by analyzing and interpreting glucose monitoring data from compatible Abbott meters or continuous glucose monitors (CGMs). It helps users review trends, patterns, and fluctuations in their glucose levels to make informed decisions about diabetes management, such as adjusting insulin doses or lifestyle changes.
Is the Freestyle Auto-Assist Software Version 2.0 a standalone application, and what devices is it compatible with?
Yes, the software is supplied as a standalone digital application and is specifically intended for use with compatible Abbott diabetes care meters. It does not require physical hardware beyond the meter itself, making it a software-only solution for glucose data analysis.
How was the regulatory pathway for this software determined, and what type of clearance does it hold?
The Freestyle Auto-Assist Software Version 2.0 received a FDA 510(k) clearance (K123089) under the Traditional 510(k) review pathway, classified under Clinical Chemistry (Product Code: NBW). The submission was deemed substantially equivalent to a predicate device, meaning it was evaluated for safety and performance against an existing approved product rather than undergoing a full de novo review.
Does this software have any physical specifications, such as size or MRI safety considerations, that users should be aware of?
The regulatory submission for this software does not include any physical specifications like dimensions, weight, or MRI safety information. Since it is a digital application, these factors are irrelevant, but users should confirm compatibility with their devices and ensure proper software installation on their chosen platform (e.g., smartphone, tablet, or computer).