# K040796: Accu-Chek GO System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 22, 2004 after 24 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031755 (2003). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031755: Accu-Chek Compact Test Strip, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K082169: Pro Glucose Test Strip (2008), 10 descendants of its own
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277 (2010), 6 descendants of its own
- K190579: TD-4183 Blood Glucose Monitoring System (2019), 1 descendant of its own
- K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 (2010), 1 descendant of its own
- K222126: VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (2024), 0 descendants of its own

## Recalls of this device
- May 13, 2009 · Not classified · Z-1595-2009: The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- Jun 7, 2005 · Not classified · Z-1370-05: The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiti

## Indications for use
The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose 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 and venous blood samples; lay use is limited to capillary whole blood testing.

Source page: https://510kreport.com/device/K040796
Methodology: https://510kreport.com/methodology