# K043197: Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: May 20, 2005 after 183 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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® Test Strip: named in the summary without a submission number
- (no number) OneTouch® Ultra® Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) OneTouch® InDuo® Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) OneTouch® UltraSmart® Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K080639: Symphony Glucose Management System (2008), 2 descendants of its own
- K062555: Ebsensor Blood Glucose Monitoring System, Model EB-G (2006), 2 descendants of its own
- K122181: Ebchek Blood Glucose Monitoring System (2013), 0 descendants of its own
- K091765: Ebcarryon Blood Glucose Monitoring System (2010), 0 descendants of its own
- K083225: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System (2009), 0 descendants of its own

## Recalls of this device
- Nov 1, 2005 · Not classified · Z-0435-06: Product may be defective and may give low inaccurate glucose results.
- Oct 19, 2005 · Not classified · Z-0273-06: Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
- Oct 10, 2005 · Not classified · Z-0272-06: Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters

## Indications for use
The OneTouch® Ultra® Blood Glucose Monitoring System is intended to be used for 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 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, arm or palm. The OneTouch® InDuo® System is intended to be used for quantitative measurement the body of glucose in fresh capillary whole blood. The OneTouch® Ultra® System is intended for use outside (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® InDuo® Blood Glucose Meter also functions as the cap for the InDuo® Insulin Doser. The two devices fit together to form a single unit for user convenience. The OneTouch InDuo® Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm. The OneTouch® UltraSmart® System is intended to be used for 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 healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraSmart® Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medicationa data port that enables the user to download electronic data to a personal computer. The OneTouch® UltraSmart® Smart Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.

Source page: https://510kreport.com/device/K043197
Methodology: https://510kreport.com/methodology