# K123089: Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 5, 2013 after 186 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952279 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062770: Copilot Health Management System, Abbott Diabetes Care, Inc. (2006) Summary page 1.

## Indications for use
The Freestyle Auto-Assist Software Version 2.0 is intended for use by people with diabetes to aid in the review, analysis and evaluation of information such as blood glucose results, blood ketone test results and other data uploaded from a compatible meter, such as insulin doses and exercise data from the Freestyle lnsulinx meter, in support of an effective diabetes health management program. Freestyle Auto-Assist software isnot intended for the diagnosis of or screening for diabetes mellitus

Source page: https://510kreport.com/device/K123089
Methodology: https://510kreport.com/methodology