# K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Feb 7, 2003 after 49 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
83 later devices descend from it; 15 cite it directly.
0 of 84 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) One Touch Ultra Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) One Touch InDuo Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K080923: Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB (2008), 22 descendants of its own
- K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color) (2009), 21 descendants of its own
- K042678: Rightest Blood Glucose Monitoring System (2005), 18 descendants of its own
- K053635: Modification to Rightest Blood Glucose Monitoring System (2006), 17 descendants of its own
- K062567: Rightest Blood Glucose Monitoring System (2007), 16 descendants of its own

## Recalls of this device
- Apr 11, 2005 · Not classified · Z-0821-05: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Apr 11, 2005 · Not classified · Z-0822-05: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Apr 11, 2005 · Not classified · Z-0823-05: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Nov 21, 2003 · Not classified · Z-1596-05: LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hypergl
- Nov 17, 2003 · Not classified · Z-0887-05: A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.

## Indications for use
The One Touch0 Ultra@ System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The One Touch@ Ultra0 System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control. The One Touch@InDuoTMBlood Glucose Meter is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The InDuoTM Blood Glucose Meter is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control. The One Touch@InDuoTMBlood Glucose Meter also functions as the cap for the InDuoTM Insulin Doser. The two devices fit together to form a single unit for user convenience.

Source page: https://510kreport.com/device/K024194
Methodology: https://510kreport.com/methodology