# K923544: One Touch Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Dec 3, 1992 after 140 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113135: Unistrip 1 (2013), 2 descendants of its own
- K160038: UniStrip1 Generic Blood Glucose Test Strips (2016), 1 descendant of its own
- K162430: UniStrip1 Generic Blood Glucose Test Strips (2017), 0 descendants of its own
- K052207: Accurex Glucose Test Strip (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K923544
Methodology: https://510kreport.com/methodology