# K062195: Modification to One Touch Ultra Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Lifescan, Inc.
- Decided: Aug 16, 2006 after 15 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OneTouch Ultra Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K110074: HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood Glucose System (2012), 0 descendants of its own

## Recalls of this device
- Mar 16, 2021 · Class II · Z-1938-2021: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Mar 16, 2021 · Class II · Z-1936-2021: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Feb 25, 2013 · Class II · Z-1129-2013: When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial
- Jan 7, 2010 · Not classified · Z-2639-2010: One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
- Sep 19, 2008 · Not classified · Z-0004-2009: Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
- Mar 22, 2007 · Not classified · Z-1042-2007: Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim.

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

Source page: https://510kreport.com/device/K062195
Methodology: https://510kreport.com/methodology