# K113135: Unistrip 1

- Pathway: 510(k) (Traditional)
- Applicant: Unistrip Technologies, LLC
- Decided: Nov 6, 2013 after 744 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- 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

## Indications for use
The Unistripi Test Strips are used with the OneTouch® Ultra®. OneTouchi Ultra2a. One-Fouch®o Ultralvini® and One-Touch® UltraSmart® meters purchased before October 2012, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The Unistripl is meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control. They are for single patient use only and should not be shared. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearmn. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. UniStrip I Test Strips allow alternate site testing (AST) from the finqertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®Ultra meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).

Source page: https://510kreport.com/device/K113135
Methodology: https://510kreport.com/methodology