# K093745: One Touch Verio Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Feb 11, 2011 after 434 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: 1 generation back to K053529 (2006). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053529: Onetouch Ultra 2 Blood Glucose Monitoring System, Lifescan, Inc. (2006) Summary page 1.
- K072543: Onetouch Select Blood Glucose Monitoring System, Lifescan, Inc. (2007) Summary page 1.

## Most influential descendants
- K110637: Onetouch Verio (TM) IQ Blood Glucose Monitoring System (2011), 7 descendants of its own
- K131363: Onetouch Verio Blood Glucose Monitoring System (2013), 6 descendants of its own
- K150214: OneTouch Verio Flex Blood Glucose Monitoring System (2015), 4 descendants of its own
- K193475: OneTouch Verio Reflect Blood Glucose Monitoring System (2020), 1 descendant of its own
- K240640: Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (2024), 0 descendants of its own

## Indications for use
The OneTouch® Verio 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 or palm. The OneTouch® Verio Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® Verio 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® Verio 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 OneTouch® Verio Test Strips are for use with the OneTouch® Verio Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio Control Solutions are for use with the OneTouch® Verio Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K093745
Methodology: https://510kreport.com/methodology