# K141867: Accu-Chek Aviva Connect Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Mar 3, 2015 after 236 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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: 5 generations back to K010362 (2001). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133862: Accu-Chek Aviva Plus System, Roche Diagnostics Corporation (2014) Summary page 4.

## Most influential descendants
- K160944: ACCU-CHEK Guide Blood Glucose Monitoring System (2016), 3 descendants of its own
- K213131: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (2023), 0 descendants of its own
- K203711: IWL2020 Blood Glucose Monitoring System (2022), 0 descendants of its own
- K181131: Accu-Chek Guide Me Blood Glucose Monitoring System (2018), 0 descendants of its own

## Indications for use
The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Connect Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. For in vitro diagnostic use

Source page: https://510kreport.com/device/K141867
Methodology: https://510kreport.com/methodology