# K133862: Accu-Chek Aviva Plus System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corporation
- Decided: Apr 29, 2014 after 131 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010362 (2001). 5 ancestors in all.
5 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)
- K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System, Roche Diagnostics (2011)

## Most influential descendants
- K141867: Accu-Chek Aviva Connect Blood Glucose Monitoring System (2015), 4 descendants of its own
- 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

## Recalls of this device
- Jun 12, 2017 · Class II · Z-2765-2019: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
- Jun 12, 2017 · Class II · Z-2766-2019: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

## Indications for use
The ACCU-CHEK Aviva Plus 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, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Plus 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 Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Source page: https://510kreport.com/device/K133862
Methodology: https://510kreport.com/methodology