# K021943: Onetouch Profile Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Jun 28, 2002 after 31 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The ONETOUCH® Profile Meter is used for the quantitative measurement of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.

Source page: https://510kreport.com/device/K021943
Methodology: https://510kreport.com/methodology