# K032552: Accu-Chek Advantage System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 12, 2003 after 24 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
No predicates in its family tree.
73 later devices descend from it; 5 cite it directly.
1 of 74 devices in its family (counting itself) has 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) Accu-Chek Advantage System: named in the summary without a submission number

## Most influential descendants
- K043474: Accu-Chek Aviva System (2005), 63 descendants of its own
- K060620: Accu-Chek Aviva Test Strips (2006), 46 descendants of its own
- K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System (2011), 44 descendants of its own
- K111353: Accu-Check Combo System (2012), 37 descendants of its own
- K141929: Accu-Chek Connect Diabetes Management App (2015), 33 descendants of its own

## Indications for use
The Accu-Chek Advantage system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.

Source page: https://510kreport.com/device/K032552
Methodology: https://510kreport.com/methodology