# K131363: Onetouch Verio Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cilag GmbH International
- Decided: Aug 30, 2013 after 109 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: 3 generations back to K053529 (2006). 4 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K110637: Onetouch Verio (TM) IQ Blood Glucose Monitoring System, Cilag GmbH International (2011) Summary page 6.

## Most influential descendants
- 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
- K162564: Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System (2017), 0 descendants of its own

## Indications for use
The OneTouche Verioo 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 system is intended to be used by a single patient and should not be shared. The OneTouch® Verioo 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 OneTouche Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use. The OneToucho Veria® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whale drawn from the fingertips.

Source page: https://510kreport.com/device/K131363
Methodology: https://510kreport.com/methodology