# K110637: Onetouch Verio (TM) IQ Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cilag GmbH International
- Decided: Sep 7, 2011 after 187 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K053529 (2006). 3 ancestors in all.
7 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)
- K093745: One Touch Verio Blood Glucose Monitoring System, Lifescan, Inc. (2011) Summary page 2.

## Most influential descendants
- 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
- K173658: Confidence Blood Glucose Monitoring System (2018), 0 descendants of its own

## Recalls of this device
- Feb 21, 2012 · Not classified · Z-1359-2012: An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items t

## Indications for use
The OneTouch® VerioTMIQ 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 OneTouch® VerioTM IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. OneTouch® Verio TmIQ 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® Ver io TM IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use. The OneTouch® Verio TM Test Strips are for use with the OneTouch® Veri o TM IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

Source page: https://510kreport.com/device/K110637
Methodology: https://510kreport.com/methodology