# K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 21, 2011 after 499 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: 3 generations back to K010362 (2001). 4 ancestors in all.
44 later devices descend from it; 4 cite it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060620: Accu-Chek Aviva Test Strips, Roche Diagnostics Corp. (2006) Summary page 1.
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K190487: InPen Dose Calculator (2020), 10 descendants of its own

## 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 ann, or palm.

Source page: https://510kreport.com/device/K101299
Methodology: https://510kreport.com/methodology