# K082513: Onetouch Vita Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Oct 22, 2008 after 50 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The OneTouch® Vita™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Source page: https://510kreport.com/device/K082513
Methodology: https://510kreport.com/methodology