# K050872: Accu-Chek Integra System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: May 2, 2005 after 26 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: 1 generation back to K031755 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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)

## Indications for use
The Accu-Chek Integra 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. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.

Source page: https://510kreport.com/device/K050872
Methodology: https://510kreport.com/methodology