# K043529: Accu-Chek Advisor Insulin Guidance Software

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 8, 2005 after 108 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Diacare Monitoring System Software: named in the summary without a submission number

## Most influential descendants
- K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 (2010), 8 descendants of its own
- K162532: WellDoc BlueStar, WellDoc BlueStar Rx (2017), 5 descendants of its own
- K190013: WellDoc BlueStar (2019), 4 descendants of its own
- K193654: BlueStar Rx (2020), 3 descendants of its own
- K203434: BlueStar Rx (2021), 1 descendant of its own

## Indications for use
The software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management, including providing direction within the scope of a pre-planned treatment program for adjustments to prescribed insulin, similar to the directions physicians provide to patients as a part of routine clinical practice. The device is not intended to provide any diagnosis on patient results.

Source page: https://510kreport.com/device/K043529
Methodology: https://510kreport.com/methodology