# K060620: Accu-Chek Aviva Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 11, 2006 after 156 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010362 (2001). 3 ancestors in all.
46 later devices descend from it; 2 cite it directly.
1 of 50 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K160629: InPen (2016), 21 descendants of its own

## Recalls of this device
- May 13, 2009 · Not classified · Z-1593-2009: The lancet cap may be missing, which could result in an unintended lancet stick to the user.

## Indications for use
The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.

Source page: https://510kreport.com/device/K060620
Methodology: https://510kreport.com/methodology