# K052207: Accurex Glucose Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Incline Medical, LLC
- Decided: Mar 9, 2006 after 209 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
Longest line of descent: 1 generation back to K923544 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923544: One Touch Test Strips, Lifescan, Inc. (1992) Summary page 1.

## Indications for use
The Accurex Glucose Test Strip for use with the following glucometers: One Touch Basic, One Touch II and One Touch Profile meters, all manufactured by Lifescan, Inc. It is to be used for the quantitative measurement of glucose in fresh capillary whole blood. Glucose measurements are used as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K052207
Methodology: https://510kreport.com/methodology