# K051592: Modification to Accu-Chek GO System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 2, 2005 after 79 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- 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: 2 generations back to K031755 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040796: Accu-Chek GO System, Roche Diagnostics Corp. (2004) Summary page 1.

## Indications for use
The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in 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, venous and arterial blood samples; lay use is limited to capillary whole blood testing.

Source page: https://510kreport.com/device/K051592
Methodology: https://510kreport.com/methodology