# K151611: OneTouch Ultra Plus Flex Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan Europe
- Decided: Dec 14, 2015 after 182 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: 4 generations back to K053529 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131363: Onetouch Verio Blood Glucose Monitoring System, Cilag GmbH International (2013) Summary page 5.

## Indications for use
The OneTouch Ultra Plus Flex 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 fingertip. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared. OneTouch Ultra Plus Flex 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 OneTouch Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus Flex Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

Source page: https://510kreport.com/device/K151611
Methodology: https://510kreport.com/methodology