# K031472: One Touch Basic/Profile/One Touch II Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Aug 5, 2003 after 88 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 Basic/Profile/ONETOUCH II Test Strips: named in the summary without a submission number

## Most influential descendants
- K033627: Q.Steps Biometer G Blood Glucose Monitoring System (2004), 1 descendant of its own
- K050182: Q.Steps Biometer G/C Dual Monitoring System (2005), 0 descendants of its own

## Indications for use
The ONETOUCH Basic/Profile/ONE TOUCH II Test Strips are intended for use with ONETOUCH Brand meters by healthcare professionals and laypersons with diabetes at home to provide a quantitative measurement of glucose in whole blood as an aid in managing their glycemic state.

Source page: https://510kreport.com/device/K031472
Methodology: https://510kreport.com/methodology