# K043474: Accu-Chek Aviva System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 27, 2005 after 132 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010362 (2001). 2 ancestors in all.
63 later devices descend from it; 10 cite it directly.
1 of 66 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010362: Accu-Chek Comfort Curve Test Strip, Roche Diagnostics Corp. (2001) Summary page 1.
- K032552: Accu-Chek Advantage System, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- 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
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), 32 descendants of its own

## Recalls of this device
- Nov 9, 2005 · Not classified · Z-0417-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0418-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0420-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0419-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0421-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0425-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0426-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0422-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0423-06: Incorrect patient blood glucose test results may be reported due to a software problem.
- Nov 9, 2005 · Not classified · Z-0424-06: Incorrect patient blood glucose test results may be reported due to a software problem.

## Indications for use
The ACCU-CHEK® Aviva 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 blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.

Source page: https://510kreport.com/device/K043474
Methodology: https://510kreport.com/methodology